NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
|
|
- Marcus Williamson
- 6 years ago
- Views:
Transcription
1 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM 003 SOP category: Trial Management Version number: 03 Version date: 08 September 2016 Effective date: 08 October 2016 Revision due date: 08 October 2019 SOP author details Author name: Author position: Author signature: Date: Jill Peacock Quality Assurance Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. SOP authoriser details Authoriser name: Authoriser position: Authoriser signature: Date: Professor Mark Walker Interim Director, Newcastle Clinical Trials Unit This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. STATEMENT This is a controlled document. The master document is held within NCTU with a controlled copy posted on the NCTU website: Any print off of this document will be classed as uncontrolled and should not be filed. The reader is responsible for regularly checking the NCTU website for more recent versions. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 1 of 12
2 SOP revision record Version number Date Reason for revision 01 07/09/2011 Document release 02 06/09/2013 Document revision 03 16/08/2016 Update to include information on RSI, the expected procedures to be completed within NCTU and responsibilities. Table of Contents 1. BACKGROUND PURPOSE SCOPE ROLES & RESPONSIBILITES ACRONYMS PROCEDURE Standard definitions Study set up and safety considerations AE recording and reporting requirements Risk assessment RSI Reporting and recording AEs Receipt and follow up of serious adverse events Pregnancy SAE reconciliation SUSAR reporting Reporting a SUSAR within NCTU Blinded studies Non IMP Investigator notification Regular reports Development Safety Update Report Trial Oversight Committee reports Advanced Therapy Medicinal Products Expedited reporting Follow up REVIEW AND MONITORING OF THIS DOCUMENT ASSOCIATED DOCUMENTS SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 2 of 12
3 1. BACKGROUND Patient safety should always be paramount during research. It is essential that any Adverse Events (AEs) or safety issues that occur during a research project are appropriately managed, reviewed and followed up to ensure the continuing safety of study participants. For Clinical Trials of Investigational Medicinal Products (CTIMPs) there is a legal requirement for the management and reporting of AEs in accordance with the Medicines for Human Use (Clinical Trials) Regulations The regulations set out the requirements for notification and reporting of AEs and adverse reactions (ARs) during a CTIMP. There are additional requirements for clinical trials of Advanced Therapy Medicinal Products (ATMPs) outlined in Detailed guidelines on good clinical practice specific to advanced therapy medicinal products, PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the processes to be followed for assessing, recording, notifying and reporting safety information in accordance with the regulatory requirements for CTIMPs and ATMPs. 3. SCOPE This SOP applies to all personnel within Newcastle Clinical Trials Unit (NCTU) who have involvement in any aspect of safety reporting, including trend analysis. The procedures within the SOP apply when NCTU has been delegated the duty of safety reporting and pharmacovigilance on behalf of the research sponsor. It is the responsibility of the Trial Manager to refer to the agreement with the sponsor to determine the responsibilities of NCTU with respect to safety reporting. This SOP does not include Urgent Safety Measures which are covered in NCTU SOP TM ROLES & RESPONSIBILITES The sponsor is responsible for the ongoing safety evaluation of the Investigational Medicinal Product (IMP) or ATMP however may delegate these tasks to the Chief Investigator (CI) or NCTU. Specific roles and responsibilities are covered in the relevant sections of the SOP however as a general rule it is the responsibility of the Trial Manager to ensure compliance with the regulations. The Trial Manager may delegate specific tasks to other personnel, e.g. a clinical trial administrator, however must retain oversight of these tasks. Safety trend analysis and overarching review of safety data is the responsibility of the Data Monitoring Committee or Trial Oversight Committee where applicable. All parties are responsible for ensuring they observe a duty of care with regards to patient safety and related reporting. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 3 of 12
4 5. ACRONYMS AE AR ATMP CESP CI CTIMP DIBD DSUR esusar IMP MHRA NCTU NIMP PI QA REC RSI SAE SAR SOP SUSAR Adverse Event Adverse Reaction Advanced Therapy Medicinal Product Common European Submission Portal Chief Investigator Clinical Trial of an Investigational Medicinal Product Development International Birth Date Development Safety Update Report electronic Suspected Unexpected Serious Adverse Reaction reporting system Investigational Medicinal Product Medicines and Healthcare products Regulatory Agency Newcastle Clinical Trials Unit Non Investigational Medicinal Product Principal Investigator Quality Assurance Research Ethics Committee Reference Safety Information Serious Adverse Event Serious Adverse Reaction Standard Operating Procedure Suspected Unexpected Serious Adverse Reaction 6. PROCEDURE 6.1 Standard definitions Term Adverse Event Adverse Reaction Causality Expected Reference Safety Information (RSI) Definition Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. Any untoward and unintended response in a subject to an IMP which is related to any dose administered to that subject. The assessment of the root cause of an AE to determine if the IMP(s) under study was a factor. An AR/Serious AR that has been included in the approved Reference Safety Information. The RSI is the list of known side effects of the IMP(s) under study and the information used to assess the expectedness of an AR/Serious AR. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 4 of 12
5 Sequelae Serious Suspected Unexpected Serious Adverse Reaction (SUSAR) Severity Unexpected A condition following or occurring as a consequence of another condition or event. An AE or AR is serious if it meets one of the following criteria: results in death is life threatening (i.e. the participant was at risk of death at the time of the event rather than an event that hypothetically might have caused death if it were more severe) requires hospitalisation or the prolongation of existing hospitalisation results in persistent or significant disability or incapacity is a congenital anomaly or birth defect; or is medically important (i.e. the event jeopardised the immediate health of the participant or required intervention to prevent event becoming serious) Any AR that is classed as serious and unexpected. The scale of determining the grade of the event e.g. mild, moderate and severe. Severity is not the same as seriousness and an AE can be severe without meeting the criteria of being serious. An AR/Serious AR not included in the RSI or AR/Serious AR that is listed but the frequency or severity of the event is not consistent with the information within the RSI. 6.2 Study set up and safety considerations Safety reporting requirements must be considered early during the development of a study and the protocol. It is important to ensure that all relevant parties are included in these discussions, preferably through the Trial Management Group, to ensure the procedures are robust AE recording and reporting requirements Specific requirements/procedures for assessing, recording, notifying and reporting AEs must be clearly defined in the study protocol, including the specific timelines to be followed. This includes details of delegated responsibilities where appropriate. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 5 of 12
6 The overarching study timeframe for reporting AEs must also be specified e.g. to record AEs from point of consent or from point of study intervention. AE recording may stop at the end of treatment or follow up however any Serious Adverse Event (SAE) that comes to the attention of the site team must be recorded and reported up until the point of study closure. Certain events which meet the criteria of serious may be exempted from SAE reporting in certain circumstances however this must be justified through the risk assessment for the study. Any events which are exempted from SAE reporting should be specified in the protocol Risk assessment RSI A documented risk assessment must be conducted, prior to obtaining the research approvals, to define the level of safety monitoring and reporting required for each study. Lower risk studies with a known safety profile may just require the recording of SAEs or it may be appropriate to exclude SAE recording of those expected events that are recorded and monitored as outcome measures. The level of safety monitoring and reporting determined by the risk assessment must be authorised by the sponsor prior to implementation. The risk assessment must also include an assessment of the risk of the IMP passing to the embryo or foetus in the event that a study participant, or partner of a study participant, becomes pregnant during the study. Acceptable contraceptive measures must be described in the protocol as well as the process to be followed in the event that a participant, or their partner, becomes pregnant. The RSI is the list of known adverse reactions for the IMP/IMPs under study and must be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as part of the original Clinical Trial Authorisation or through a substantial amendment in the event of an update to the RSI. Only the approved RSI can be used to assess the expectedness of any SAR that occurs during the trial. It is the sponsor s responsibility to determine the RSI for the trial however this task may be delegated to the CI. In general the RSI may be a section within the Investigator Brochure (for IMP without a Marketing Authorisation or being used outwith of the current Marketing Authorisation) or the Summary of Product Characteristics (for IMP with a Marketing Authorisation and being used within the licensed indication). However, the CI must take into account the participant population to be studied and the current available information e.g. it is not acceptable to use the list of undesirable effects observed in patients with Chronic Myeloid Leukaemia when the participant population will be unconscious individuals in critical care. There can only be one RSI for each IMP under study. In the event that there may be several lists of undesirable effects from multiple sources, e.g. different generic manufacturers or multiple doses of the same IMP, these must be reviewed and either SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 6 of 12
7 one chosen as the designated RSI or an amalgamated list prepared for approval by the MHRA as the approved as the RSI. Further information on RSI can be found in the NCTU Reference Safety Information Working Instruction. 6.3 Reporting and recording AEs The requirements for recording and reporting AEs by sites must be included in the protocol. It is the responsibility of designated site personnel to collect and record AEs in accordance with the protocol. This includes ensuring that the information is captured in the participant s medical notes (and any other relevant source data) as part of ongoing clinical care. 6.4 Receipt and follow up of serious adverse events SAEs will be received into NCTU either by fax, fax to system or via . The trial management personnel must ensure that the NCTU Quality Assurance (QA) Manager receives a copy of each SAE, preferably as a member of the SAE distribution list. The sponsor should be consulted as to how they will retain oversight of SAE reporting i.e. through receipt of each individual SAE or through receipt of a periodic report listing the SAEs received during a set time period. This must be documented, preferably through a formal agreement with the sponsor, and this documentation filed in the Trial Master File. The initial report of an SAE may be received via verbal notification but this must be followed by a completed SAE form. Upon receipt, the SAE form should be checked by the trial management personnel for: Completeness is all the necessary minimum information present? Event has an appropriate event term been given? Seriousness does the event meet the criteria of seriousness? Causality has the event been assessed by a delegated, medically qualified member of the study team as having a causal relationship to the IMP(s) under study? Expectedness if a causal relationship is suspected, has the event been assessed by a delegated member of the study team or sponsor and classed as unexpected in accordance with the approved RSI? Signatures are the required signatures present and are these by personnel listed as being able to do so on the delegation log? All confirmed SAEs, i.e. those that meet the seriousness criteria, should be logged by the Trial Manager or designee on the trial s safety database, allocated a unique SAE number and a confirmation of receipt returned to the sender. The confirmation of receipt should include the assigned SAE number as well as any requests for missing information or necessary clarifications. The SAE form and related correspondence must be filed in the Trial Master File. SAEs must be followed up by the Trial Manager until resolution even if the affected participant has withdrawn from the trial. An SAE is considered to have resolved if the outcome has been classed as: SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 7 of 12
8 Completely Recovered Recovered with Sequelae Condition stable and no change anticipated Participant Died Unresolved SAEs must be followed up with the relevant site on a regular basis until completion. The frequency of this follow up will be determined by the circumstances of the individual SAE, e.g. acute versus chronic conditions/events, as well as the design of the study Pregnancy The standard definition of a SAE includes congenital anomalies or birth defects. Pregnancy itself does not constitute a SAE but study participants that become pregnant or aid in the conception of a child must be followed up until at least the culmination of the pregnancy to determine if a congenital anomaly or birth defect has occurred. The follow up period will be determined by the known or suspected potential for the IMP to cause harm to the foetus in accordance with the risk assessment. If the IMP is known to cause congenital anomalies that are not identifiable upon birth then the follow up period must reflect this. 6.5 SAE reconciliation Upon notification that a study participant or partner of a study participant is pregnant, the Trial Manager should request that the clinical site staff complete a pregnancy reporting form and this information must be recorded on the pregnancy tracker. Informed consent must be sought from the participant, and their partner if applicable, in order for the pregnancy to be tracked and information on the outcome of the pregnancy obtained. In the event that a congenital anomaly or birth defect does occur, this must be reported as a SAE. The Trial Manager must ensure that any reports of pregnancy are notified to the sponsor and CI within 24 hours of receipt. SAE reconciliation should be conducted on a regular basis, unless the study is due to run for a year or less in which case it is acceptable to conduct the SAE reconciliation at the end of the trial. The reconciliation process should involve a review of the information within the SAE report and ensuring this information is consistent with the information held in the study database. The Trial Management Group must determine the data items to be reconciled and how this will be achieved. This should be documented in the Data Management Plan for the study. 6.6 SUSAR reporting SARs that have been classed as unexpected, in accordance with the approved RSI, must be reported to the MHRA and Research Ethics Committee (REC) in accordance with the regulatory timelines: Fatal/life threatening SUSARs: must be reported as soon as possible but no later than 7 calendar days after the Sponsor or delegate becomes aware of the event. Any SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 8 of 12
9 relevant follow up information must be sought and reported within a further 8 calendar days. Non fatal and non life threatening SUSARs: must be reported as soon as possible, but no later than 15 calendar days after the Sponsor or delegate has first knowledge of the minimum criteria for expedited reporting. Further relevant follow up information should be provided within a further 15 calendar days. Day 0 of the reporting timeline starts when the following minimum information has been obtained: a valid EudraCT number a sponsor study number one identifiable coded participant (e.g. participant study number) one identifiable reporter (e.g. Principal Investigator (PI)) one SUSAR one suspect IMP a causality assessment Upon receipt of a potential SUSAR, the Trial Manager must contact the sponsor to determine the appropriate course of action. Where the sponsor retains the duty for reporting SUSARs, the Trial Manager should cooperate fully with the sponsor s process and provide any requested assistance in a timely manner. The Trial Manager must also request a copy of all relevant documentation from the sponsor for filing within the Trial Master File e.g. copy of esusar form, copy of correspondence with the REC etc Reporting a SUSAR within NCTU Where NCTU has been delegated the duty for reporting SUSARs, the Trial Manager must contact the NCTU QA Manager to obtain access to the MHRA s electronic SUSAR (esusar) system. In the event that the NCTU QA Manager is not present, access can be granted by the Senior Trial Managers. The Trial Manager must complete the esusar form with input from the CI, relevant PI and research sponsor. Note that the esusar form requests that both the Sponsor and CI assess the causality of the event. Once the form has been completed, a draft must be saved and sent to the CI and sponsor representative for review. Comment should be returned within 24 hours. The finalised esusar form must be submitted via the esusar website and a copy printed for filing within the Trial Master File (the system allows a copy of the report to be printed after submission). A PDF copy of the form should also be saved. The Trial Manager must also notify the REC that gave the favourable ethical opinion of the SUSAR within 15 days of becoming aware of the event. Notification should be via and a copy of the completed esusar report must be submitted along with a completed CTIMP Safety Report to REC form to allow the REC to acknowledge receipt. This form does not need to be signed prior to submission. The REC Coordinator will acknowledge receipt of the report within 30 days by signing and returning a copy of the submitted CTIMP Safety Report to REC form. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 9 of 12
10 This procedure must be repeated if a follow up report is submitted with any relevant, additional information. All forms and related correspondence must be filed within the Trial Master File Blinded studies Maintenance of the blind is vital for the integrity of the trial. Systems for expedited and annual safety reporting should, as far as possible, maintain blinding of individual clinicians and of staff involved in the day to day running of the trial. Unblinding may be unavoidable if the information is necessary for the medical management of a particular participant. In a placebo controlled CTIMP the assessment of seriousness, causality and expectedness should be made as though the patient was on active drug. Cases considered serious, unexpected and related (i.e. SUSARs) require unblinding and only those events occurring among patients on the active drug must be reported. However, if the participant is found to be on placebo and the event is considered associated with the placebo (e.g. a reaction to an excipient or impurity within the formulation) such cases must also be reported as a SUSAR to the MHRA. In blinded CTIMPs with multiple IMP (e.g. comparators) those events assessed as being serious and having a possible causal relationship to one of the IMP under study must be unblinded. Again, those events that meet the fully definition of a SUSAR require expedited reporting. All parties must following the process outlined in the protocol for unblinding participants Non IMP SARs thought to be related to Non IMP (NIMP) must be expedited if: The event might be linked to either a NIMP or IMP but it is not possible to attribute causality The event may be linked to an interaction between a NIMP and the IMP The reaction due to the NIMP is likely to affect the safety of the trial subjects Investigator notification 6.7 Regular reports The Trial Manager must ensure that all investigators for a study are informed of any SUSAR that occurs in relation to the IMP used in that study or on another study for which the Sponsor is responsible. Documentary evidence of the investigator review must be filed within the Investigator Site File e.g. through signing and dating the report or reply . Consideration must be given to blinded studies and the format that the notification takes in order to maintain the blind. SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 10 of 12
11 Development Safety Update Report A Development Safety Update Report (DSUR) must be submitted to the MHRA and NHS REC once a year on the anniversary of the Development International Birth Date (DIBD). The Trial Manager must ensure that the report is submitted within 60 days of the end of the reporting period. The Trial Management Group must input into the compilation of the DSUR and the CI must review and authorise the final report before it is ready for submission. The DSUR should also be reviewed by the NCTU QA Manager and Sponsor Representative prior to submission via the Common European Submission Portal (CESP) system. Further information on DSURs can be found in the NCTU Development Safety Update Report Working Instruction Trial Oversight Committee reports Regular reports of unblinded data must be compiled and provided to the Data Monitoring Committee or Trial Oversight Committee, as appropriate, to enable the committee to fulfil their responsibilities for patient safety. The Data Monitoring Committee/Trial Oversight Committee should use this information to look for any safety signals that may require further action and this information passed on to the Trial Steering Committee or Sponsor directly. 6.8 Advanced Therapy Medicinal Products Requirements for ATMPs differ from other CTIMPs particularly with regard to expedited reporting and follow up Expedited reporting In addition to those events that meet the criteria of a SUSAR, the following SAEs must also be reported: SAEs associated with trial procedures SAEs associated with product failure including a lack of efficacy of the trial product SAEs related to mandatory concomitant medications SAEs which are deemed a significant hazard to the participant population SAEs due to infection Unexpected reactions SAEs due to medical devices that form part of the product or used to deliver the ATIMP All such SAEs must be reported to the MHRA as described in section Follow up SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 11 of 12
12 The duration and nature of follow up should be determined by a risk assessment of the current knowledge of the ATMP, its mode of action and the risk to close contacts as well as offspring. Advice can be sought from the MHRA as to the period and type of follow up expected. 7. REVIEW AND MONITORING OF THIS DOCUMENT This SOP will be reviewed every three years unless there is a change to the applicable legislation or significant revision to the process contained in the SOP. Compliance with this SOP will be monitored through Senior Trial Manager oversight at regular scheduled 1:1 meetings with Trial Managers and through a standing pharmacovigilance agenda item at Trial Management Group Meetings. In addition, compliance with the requirements of this SOP will be assessed through the annual internal audit schedule. 8. ASSOCIATED DOCUMENTS NCTU Development Safety Update Report Working Instruction NCTU Reference Safety Information Working Instruction NCTU Processing Serious Adverse Events Guidance Document SOP NCTU: TM 003 Version: 03 Version date: 08 SEP 2016 Page 12 of 12
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM-003 SOP category: Trial Management Version number: 04 Version date:
More informationStandard Operating Procedure
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-07-004 Recording, managing and reporting Adverse Events for Clinical Trials of Investigational Medicinal Products and trials of Advanced
More informationSponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law
EU Directives Pharmacovigilance Legislation, SOPs and Reporting Louise Boldy, Governance & Safety Manager David Martin, Pharmacovigilance Monitor EU Legislation 2001/20/EC 2005/28/EC EudraLex Vol 10 UK
More informationDetails: Approval: Distribution & Storage: Pharmacovigilance for Researchers for UoL / LTHT Sponsored CTIMPs. Standard Operating Procedure
Details: Author: Razwan Mahroof - QA Clinical Trials Monitor SOP Pages: 10 Version No. of replaced SOP: 1.0 Effective date of replaced SOP: 04 December 2015 Approval: Version No: of the SOP being approved.
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title Safety Reporting and Pharmacovigilance SOP Index Number SOP 20 Version 4.0 Approval Date 31-Jan-2017 Effective Date 14-Feb-2017
More informationMarie-Claire Rickard, RG and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance processing for the JRMO SOP Number: 26c Version Number: V1 Effective Date: 5/8/16 Review Date: 5/8/17 Author: Reviewer: Reviewer: Authorisation:
More informationSafety Reporting in Clinical Research Policy Final Version 4.0
Safety Reporting in Clinical Research Policy Final Version 4.0 Category: Summary: Equality Assessment undertaken: Impact Policy The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Adverse Event Identification, Recording and Reporting in Clinical Trials of Investigational Medicinal SOP-RES-019 Version Number 2 Issue Date 08 th Dec
More informationSTANDARD OPERATING PROCEDURE SOP 205
STANDARD OPERATING PROCEDURE SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs Sponsored by the Norfolk and Norwich University Hospital NHS Foundation Trust Version 2.3 Version date
More informationResearch Adverse Event and Safety Reporting Procedures Outcome Statement: Title:
Title: Research Adverse Event and Safety Reporting Procedures Outcome Statement: Research Teams will be able to correctly identify and report Adverse Events and complete Annual Safety Reports for research
More informationReference Number: UHB 253 Version Number: 1 Date of Next Review: 22/01/2018 Previous Trust/LHB Reference Number: SR-RG-015
Reference Number: UHB 253 Version Number: 1 Date of Next Review: 22/01/2018 Previous Trust/LHB Reference Number: SR-RG-015 Safety Reporting in CTIMPs Standard Operating Procedure Introduction and Aim The
More informationVersion Number: 003. On: September 2017 Review Date: September 2020 Distribution: Essential Reading for: Information for: Page 1 of 13
CONTROLLED DOCUMENT Reporting Research Incidents and Breaches Policy CATEGORY: CLASSIFICATION: PURPOSE Controlled Number: Document Policy Governance To set out the framework and principles for reporting
More informationM. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance and Safety Reporting for Sponsored non-ctimps SOP Number: 26b Version 2.0 Number: Effective Date: 29th November 2015 Review Date: 3 rd December
More informationPOLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING
POLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING CLASSIFICATION TRUST POLICY NUMBER APPROVING COMMITTEE R & D Governance Committee RATIFYING COMMITTEE Quality & Risk Committee DATE RATIFIED October 2009
More informationIDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES
IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES DOCUMENT NO.: CR012 v2.0 AUTHOR: Raymond French ISSUE DATE: 18 September 2017 EFFECTIVE DATE: 02 October
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Recording, Managing and Reporting Adverse Events SOP Number: 2 Version Number: 3.0 Supersedes: 2.1 Effective date: May 2013
More informationSOP19a & 19b: Standard Operating Procedure for (a) Safety Monitoring (especially Pharmacovigilance) & (b) Urgent Safety Measures
SOP19a & 19b: Standard Operating Procedure for (a) Safety Monitoring (especially Pharmacovigilance) & (b) Urgent Safety Measures Authorship Team: Anne Seagrove, Melanie Storey, Ian Russell for Joint SOP
More informationThis Agreement dated DD/MM/YYYY (the Effective Date ) is between
Clinical Trial Delegation of Sponsorship Responsibilities to Chief This Agreement dated DD/MM/YYYY (the Effective Date ) is between Nottingham University Hospitals NHS Trust, Derby Road, Nottingham, NG7
More informationTITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18
SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Urgent Safety Measures SOP-RES-022 Version Number 1 Issue Date 30 th April 2014 Effective Date 28 th May 2014 Review Date 28 th May 2016 Author(s) Reviewer(s)
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM-005 SOP category: Trial Management Version number: 04 Version date: 10 July
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting
Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD,
More informationStandard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research
Standard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/002 Version V2.0 07 Apr 2016 Document Author(s) Document Reviewer(s)
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM 005 SOP category: Trial Management Version number: 03 Version date: 19 December
More informationVersion Number: 004 Controlled Document Sponsor: Controlled Document Lead:
Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA IMPORTANT NOTE This guideline applies only to the reporting of SAEs during clinical trials. An update of the guideline for this
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Adverse Event Reporting in Clinical Medical Device Trials SOP-RES-033 Version Number 1 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review
More informationRITAZAREM CRF Completion Guidelines
RITAZAREM CRF Completion Guidelines 10 Sept 2013 Version 1.2 Author: Michelle Lewin RITAZAREM Trial Coordinator Michelle.lewin@addenbrookes.nhs.uk Tel: +44(0) 1223 349350 Fax: +44(0) 1223 586767 Version
More informationStandard Operating Procedure (SOP)
Standard Operating Procedure MANAGEMENT OF BREACHES IN RESEARCH SETTING AUDIENCE ISSUE Trustwide for research sponsored by UHBristol All research staff involved in UH Bristol sponsored research This SOP
More informationResearch Governance Framework 2 nd Edition, Medicine for Human Use (Clinical Trial) Regulations 2004
Title: Outcome Statement: Research Auditing and Monitoring Procedures Researchers in the Trust and research partners will be informed about the requirements and procedures involved in research audit and
More informationAdverse Event Reporting
Adverse Event Reporting The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.thh.nhs.uk/departments/research/research.htm
More informationMEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS Memorandum of understanding between MHRA, COREC and GTAC
MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 Memorandum of understanding between MHRA, COREC and GTAC 1. Purpose and scope 1.1 Regulation 27A of the Medicines for Human Use (Clinical Trials)
More informationSOP-QA-28 V2. Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head
More informationMANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS
MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS DOCUMENT NO.: CR010 v4.0 AUTHOR: Heather Charles ISSUE DATE: 01 September 2016 EFFECTIVE DATE: 15 September 2016 1 INTRODUCTION 1.1 The Academic
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title SOP Index Number SOP 21 Version 4.0 Approval Date Effective Date Non-Compliance: Deviations and Serious Breaches of GCP and/or
More informationQuality Assurance in Clinical Research at RM/ICR. GCP Compliance Team, Clinical R&D
Quality Assurance in Clinical Research at RM/ICR GCP Compliance Team, Clinical R&D Slide 1 of 13 What is Quality Assurance? The maintenance of a desired level of quality in a service or product, especially
More informationFERCI MODEL SOPs. [The IEC members (author/s, reviewer/s) and Chairperson will sign and date the SOP on this first page]
Title: SOP Code: SOP 12/V1 [The IEC members (author/s, reviewer/s) and Chairperson will sign and date the SOP on this first page] Prepared by: Dr. Padmaja Marathe, FERCI Member (Signature with Date) Reviewed
More informationPROMPTLY REPORTABLE EVENTS
PROMPTLY REPORTABLE EVENTS PURPOSE AND SCOPE To define the structure and responsibility for reporting unanticipated problems that occurs during the conduct of research. APPLICABLE REGULATIONS Policy II.02
More informationStandard Operating Procedure:
Standard Operating Procedure: Preparation and Submission of Annual Progress Reports for all Research Projects and Development Safety Update Reports SOP Number: SOP-QA-21 Version No: 1 Author: Date: 1-9-15
More informationStandard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research
Standard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/006 Version V1.1 07 Apr 2016 Document Author(s) Document
More informationNew European Union Clinical Trial Regulations
New European Union Clinical Trial Regulations Incorporate Monitoring and Safety Reporting Techniques into U.S. and EU Clinical Trial SOPs Anita K. Murthy Deputy Director, Global Regulatory Affairs Bayer
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Risk Assessment of NCTU Studies SOP number: TM-020 SOP category: Trial Management Version number: 02 Version date: 16
More informationI. Scope This policy defines unanticipated problems and adverse events and establishes the reporting process and timeline.
Human Research Protection Program Policies & Procedures Unanticipated Problems and Adverse Events Version 3.0 Date Effective: 11.9.2012 Research Integrity Office Mail code L106-RI Portland, Oregon 97239-3098
More informationAdverse Event Reporting
Adverse Event Reporting Clinical S.O.P. No.: 15 Compiled by: Approved by: Review date: November 2016 DOCUMENT HISTORY Version Detail of purpose / change Author / edited Date edited number by 1.0 New SOP
More informationDocument Number: 006. Version: 1. Date ratified: Name of originator/author: Heidi Saunders, Senior Portfolio Coordinator
including Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (Clinical Trials of Investigational Medicinal Products) Document Number: 006 Version: 1 Ratified
More informationStudy Monitoring Plan Template
Study Monitoring Plan Template Sponsor Reference Number: Study Title: Principal Investigator: Study Centre: The Sponsor risk assessment form and the trial risk based monitoring strategy appendices 2 &
More informationStandard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH. Chief and Principal Investigators of research sponsored and/or hosted by UHBristol
Standard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH SETTING FOR STAFF ISSUE Trustwide Chief and Principal Investigators of research sponsored and/or hosted by UHBristol Oversight of research
More informationSOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY. Contact Jess Bisset, Research Operations Manager x20227
SOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY SETTING FOR STAFF QUERIES Trust wide All staff involved in research Contact Jess Bisset, Research Operations Manager x20227 Guidance 1. Introduction In accordance
More informationResearch Staff Training
REFERENCE: VERSION NUMBER: 3.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Research Infrastructure Manager REVIEWED BY: Research & Innovation Group APPROVED BY: Deputy Director of Research CONTROLLER:
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Delegated Responsibilities in Research Projects SOP Number: 11 Version Number: 2.0 Supercedes: 1.0 Effective date: August
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Risk Assessment SOP-RES-002 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
More informationStudy Guide for Emergency Care Clinicians. (Version /09/2014)
Study Guide for Emergency Care Clinicians (Version 1.2 26/09/2014) Notes 1. These learning materials are aimed primarily at paramedics, ambulance nurses, emergency care practitioners and doctors recruiting
More informationMHRA Findings Dissemination Joint Office Launch Jan Presented by: Carolyn Maloney UHL R&D Manager
MHRA Findings Dissemination Joint Office Launch Jan. 2012 Presented by: Carolyn Maloney UHL R&D Manager Purpose of presentation To feed back abridged findings from March 2011 MHRA Statutory Systems Inspection
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Recording and Reporting Deviations, Violations, Potential Serious Breaches, Serious Breaches and Urgent Safety Measures
More informationSTANDARD OPERATING PROCEDURE SOP 710. Good Clinical Practice AUDIT AND INSPECTION. NNUH UEA Joint Research Office. Acting Research Services Manager
STANDARD OPERATING PROCEDURE SOP 710 Good Clinical Practice AUDIT AND INSPECTION Version 1.3 Version date 27.02.2018 Effective date 3.03.2018 Number of pages 10 Review date February 2020 Author Role Approved
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Report SOP-RES-027 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s) Natalie
More informationI2S2 TRAINING Good Clinical Practice tips. Deirdre Thom Neonatal Nurse Coordinator
I2S2 TRAINING Good Clinical Practice tips Deirdre Thom Neonatal Nurse Coordinator Content Principal investigator (slides 3-5) Delegation and delegation log (slides 6-7) Informed consent (slides 8-15) Data
More informationStandard Operating Procedure. Essential Documents: Setting Up a Trial Master File. SOP effective: 19 February 2016 Review date: 19 February 2018
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-06-003 Essential Documents: Setting Up a Trial Master File SOP effective: 19 February 2016 Review date: 19 February 2018 SOP author signature:
More informationJoint R&D Support Office SOP S-2011 UHL
UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES Joint R&D Support Office SOP S-2011 UHL Site Initiation for
More informationGovernance %%.4- r2&% Queen s University Belfast. Standard Operating Procedure Research Governance. r2.aoc7. Research and Enterprise
Queen s University Belfast Research and Enterprise Standard Operating Procedure Research Governance Title: Delegation of Responsibilities SOP Reference QUB-ADRE-005 Date prepared 23 June 2008 Number: Version
More informationACTIONS/PSOP/001 Version 1.0 Page 2 of 6
1. The purpose of the Pharmacy Site File To enable the designated trust pharmacy to fulfil its role and exercise appropriate control over all aspects of study medication handling, an accurately maintained
More informationResearch & Development Quality Manual
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager Version: 3 Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School Document History
More informationGuideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted
More informationACRIN ADVERSE EVENT REPORTING MANUAL. 1 March 2006 v.3
AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK ADVERSE EVENT REPORTING MANUAL 1 Prepared by the American College of Radiology Imaging Network Administrative Center September 2002 Revised March 2006 American
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationOverview of Draft Pharmacovigilance Protocol
Overview of Draft Pharmacovigilance Protocol Identifying ADRs in Africa Special Challenges Malaria - pan-systemic clinical features Life-threatening condition Real-world trial AS/SP and co-artem safety
More informationHuman Samples in Research
Human Samples in Research Adverse Event Reporting Document Identifier HTA-11-SOP-Adverse Event Reporting AUTHOR APPROVER EFFECTIVE DATE: Name and role Signature and date Name and role Signature and date
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING OF POST-MARKETING ADVERSE DRUG REACTIONS TO HUMAN MEDICINAL PRODUCTS IN SOUTH AFRICA Important Note: Guideline 2.11 Reporting ADRs in South Africa addresses the reporting
More informationMonitoring Clinical Trials
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationBiomedical IRB MS #
Department for Human Research Protections Institutional Review Boards Biomedical IRB MS # 1035 419-383-6796 IRB.Biomed@utoledo.edu Social, Behavioral and Educational IRB MS # 944 419-530-6167 IRB.SBE@utoledo.edu
More informationTrial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs
R&D Department Trial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored
More informationDrugs and Cosmetics rules, 2013 India
Drugs and Cosmetics rules, 2013 India Dr.Pankaj Shah Professor, Dept of Community Medicine, SRMC & RI, & Member Secretary, IEC II, SRU, Chennai Three important amendments 30 th Jan 2013 1 St Feb 2013 8
More informationSOP Title: Reporting Adverse Events and New Safety Information
Page 1 of 14 General Control of medication use requires collecting field data about adverse events (AEs) resulting from medication therapy. Regulation 7(B)(2) of Pharmacists Regulations (Medical Products)
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA This document has been prepared to serve as a guideline to those reporting adverse drug reactions.
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Sponsorship SOP-RES-001 Version Number 3 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s) Teresa
More informationDCP Safety Committee. Update and Review. January 19, 2017
DCP Safety Committee Update and Review January 19, 2017 1 Overview: FDA s IND Safety Final Rule DCP s Response DCP Safety Committee Harmonizing Medical Monitors Process SAE Reporting SAE Flow Chart Process
More informationICH Topic E 2 D Post Approval Safety Data Management. Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
European Medicines Agency May 2004 CPMP/ICH/3945/03 ICH Topic E 2 D Post Approval Safety Data Management Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
More informationSTANDARD OPERATING PROCEDURE SOP 325
STANDARD OPERATING PROCEDURE SOP 325 STUDY START UP ACTIVITIES FOR CLINICAL RESEARCH TRIALS Version 1.4 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 7 Review date April 2019 Author
More informationDrugs and Cosmetics (First Amendment) Rules, 2013
Ministry : Ministry of Health and Family Welfare Department/Board : Health Notification No. : GSR53(E) Date of Notification : 30.01.2013 Drugs and Cosmetics (First Amendment) Rules, 2013 G.S.R.53(E).--Whereas
More informationM Rickard, Research Governance and GCP Manager Elizabeth Clough, R&D Governance Operations Manager Rachel Fay, Research Governance and GCP Manager
Standard Operating Procedures (SOP) for: Reporting Incidents Related to Research SOP Number: 027 Version Number: 4.0 Effective Date: 03 rd September 2015 Review Date: 02 nd September 2018 Author: Reviewer:
More informationUniversity of South Carolina. Unanticipated Problems and Adverse Events Guidelines
University of South Carolina Unanticipated Problems and Adverse Events Guidelines These guidelines define the procedures of USC for addressing unanticipated problems involving risks to research participants
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Study Management and Handover SOP-RES-012 Version Number 3 Issue Date 19 th April 2017 Effective Date 2 nd June 2017 Review Date 2 nd June 2019 Author(s)
More informationRoles of Investigators in the Managements of Clinical Trials
Roles of Investigators in the Managements of Clinical Trials Chii-Min Hwu, M.D. Section of General Medicine Department of Medicine Taipei Veterans General Hospital Learning Objectives PI Outlines How to
More informationHuman Research Ethics Review Policy
Policy Document Title: Document ID: Document Name: Human Research Ethics Review Policy PY-RSH-300305 Human Research Ethics Review Policy Version Number: 2 Revision Date: Key Words 28/10/2014 10:54:00 AM
More informationGUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/3 December 2010 GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS
More informationStandard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Research Governance Audit SOP Reference Number: QUB-ADRE-08 Date prepared 7 August 008 Version Number: Final v -6.0 Revision
More informationFINAL DOCUMENT. Global Harmonization Task Force
GHTF/SG5/N5:2012 FINAL DOCUMENT Global Harmonization Task Force Title: Reportable Events During Pre-Market Clinical Investigations Authoring Group: Study Group 5 of the Global Harmonization Task Force
More informationPreparation for an MHRA GCP Inspection including Training on New and Up-dated SOPs
Preparation for an MHRA GCP Inspection including Training on New and Up-dated SOPs 2015 Medicines and Healthcare products Regulatory Agency NHS Grampian & University of Aberdeen MHRA GCP Inspection 2015
More informationSite Closedown Checklist for UoL Sponsored CTIMP Studies
Site Closedown Checklist for UoL Sponsored CTIMP Studies Site Information Site: Study Title: UoL study number: Centre name: Investigator: Date of Visit: Date of Report Date Responses due by: List of site
More informationDocument Title: Document Number:
including Document Title: Document Number: Version: 2.0 Ratified by: Committee Date ratified: 25/01/2018 Name of originator/author: Directorate: Department: Name of responsible individual: Rachel Fay Corporate
More informationmanaging or activities.
STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 1.1 This
More informationGuidance notes for patient safety and pharmacovigilance in patient support programmes
Guidance notes for patient safety and pharmacovigilance in patient support programmes Authors: The ABPI Pharmacovigilance Expert Network Version: 2.14 Date: March 2018 Acknowledgements: We thank the many
More informationSerious Adverse Events
The REDOXS Study REducing Deaths due to OXidative Stress A randomized trial of glutamine and antioxidant supplementation in critically ill patients Serious Adverse Events This study is registered at Clinicaltrials.gov.
More informationHuman Research Governance Review Policy
Policy Document Title: Document ID: Document Name: Human Research Governance Review Policy PY-RSH-300304 Human Research Governance Review Policy Version Number: 2 Revision Date: Key Words 28/10/2014 10:40:00
More informationEuropean Medicines Agency Inspections ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS
European Medicines Agency Inspections London, 23 July 2008 EMEA/INS/GCP/197215/2005 Procedure no.: INS/GCP/3/V ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS GCP
More informationMarie-Claire Rickard, Governance and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of or the Trial Protocol SOP Number: 037 Version Number: 5.0 Effective Date: 17/6/16 Review Date: 17/6/18 Author: Reviewer: Reviewer
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Corrective and Preventative Action SOP-QMS-008 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s)
More informationR. Fay, Research Governance & GCP Manager K. Mahiouz, Clinical Trials Facilitator E. Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: BH/QMUL Sponsorship of CTIMPs, ATMPs and Clinical Trials of non- CE marked Medicinal Devices Process for Researchers SOP Number: 11a Version Number: V1.0 Effective
More informationDocument Title: Investigator Site File. Document Number: 019
Document Title: Investigator Site File Document Number: 019 Version: 1.1 Ratified by: R&D Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More information