Standard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research

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1 Standard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/006 Version V Apr 2016 Document Author(s) Document Reviewer(s) Christine Bevan, Research Facilitator Kate Greenwood, Research Manager Graham Halls, Research Governance Officer For Completion by Research Dept., SOP Controller Name of Responsible Committee Research Governance Group, (09 March 2012) Issue Date 07 April 2016 Implementation Date 07 June 2016 Review date 07 June 2017 Electronic location G:\Research and Development General - Policies and SOPS - Urgent safety measures - Issued versions The definitive versions of all Portsmouth Hospitals Trust SOPs, Templates and Forms for Research are online at If you are reading this SOP in printed form then you are reading an uncontrolled document. You must therefore verify that the version number and date given below are the most recent, by cross-checking with the Trust research website before proceeding with implementation. Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This SOP has been assessed accordingly SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 1 of 12

2 CONTENTS 1. INTRODUCTION PURPOSE SCOPE Who should use this SOP? When this SOP should be used ABBREVIATIONS & DEFINITIONS DUTIES AND RESPONSIBILITIES PROCESS PHT Hosted studies PHT Sponsored studies Temporary halt of a trial: Re-starting the trial: Study termination: TRAINING REQUIREMENTS REFERENCES AND ASSOCIATED DOCUMENTATION VERSION HISTORY LOG APPENDICES Hosted study flowchart PHT Sponsored study flowchart Training Record SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 2 of 12

3 1. INTRODUCTION Regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004: SI 2004/1031 specifies that the Sponsor or Investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety. Any urgent safety measures implemented must be reported to the Sponsor immediately and then the MHRA and REC as soon as possible and in all cases within 3 days. It is Trust policy that this is followed for all research studies (both CTIMP and Non-CTIMP studies) either sponsored by or hosted at Portsmouth Hospitals NHS Trust (PHT). This Standard Operating Procedure (SOP) provides for how this shall be reported and by whom. 2. PURPOSE The purpose of this document is to describe the Standard Operating Procedure for implementing and reporting urgent safety measures for all research studies sponsored and hosted by Portsmouth Hospitals NHS Trust (PHT). 3. SCOPE This SOP applies to all research studies Sponsored and/or hosted by PHT. This includes at other sites for which PHT is responsible. Urgent safety measures need only be reported to the MHRA if it is a Clinical Trial of an Investigational Medicinal Product (CTIMP) or a regulated trial of a medical device Who should use this SOP? All individuals involved in research studies taking place within PHT All individuals involved in research studies taking place at another site, where PHT is the Sponsor When this SOP should be used The process outlined in this SOP should be followed when an immediate hazard to the health or safety of a research participant (s) is identified and urgent changes in study conduct are either taken, or need to be implemented, before approval from the MHRA or the REC can be sought. Such immediate hazards may occur as a result of the following examples: A Serious Breach in protocol, procedures or Good Clinical Practice (GCP) A series of adverse reactions or a single case of an unexpected serious adverse reaction or an increase in the intensity or frequency of expected events and reactions Accident Incident Serious omissions in the approved protocol Urgent safety measures might include A temporary halt to the study at one site or study-wide An urgent change to study procedures The addition of new unapproved study procedures The Trust recognises that some external sponsors, networks, funders and employers may require the use of their own SOPs for the good governance of research. In such cases it is the responsibility of the Portsmouth Hospitals Trust user (including those individuals contracted to work on behalf of the Trust), to ensure that the external SOP is compatible with the procedure SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 3 of 12

4 outlined below. If the external SOP contradicts the Trust s procedure then approval must be sought in writing from the Director of Research. In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety 4. ABBREVIATIONS & DEFINITIONS CTIMP Clinical Trial of an Investigational Medicinal Product MHRA Medicines and Healthcare products Regulatory Agency PHT Portsmouth Hospitals NHS Trust REC Research Ethics Committee SOP Standard Operating Procedure TMF Trial Master File USM Urgent Safety Measure Hosted- Refers to an externally sponsored study for which Portsmouth Hospitals NHS Trust are acting as a site Sponsored- Unless otherwise specified, this refers to a study for which Portsmouth Hospitals NHS Trust are the Sponsor 5. DUTIES AND RESPONSIBILITIES Role All Studies Research team member Responsibilities To report to the Chief Investigator, host Trust, and/or Sponsor any hazards or urgent safety measure taken to protect the health and safety of study participants. Reporting procedures to be followed for hosted, externally sponsored studies should be those outlined in the study protocol or study specific SOP To immediately implement any urgent safety measures as instructed in writing by the Sponsors or designated person to protect the health and safety of their study participants. Where PHT is the Sponsor Chief Investigator To implement immediate changes to site level or study-wide procedures for the urgent protection of study participants To report all implemented urgent safety measures to the Research Office, MHRA, REC, other research sites and team members within the required time frames. To train Principal Investigators at all sites and any other study team members in this Standard Operating Procedure, as applicable. This may be delegated to the local Principal Investigator or another appropriate individual. Research Office staff on behalf as PHT as Sponsor To assist the investigator with reporting of the urgent safety measure. To review the urgent safety measure and its implications. To oversee the assessment and reporting process Research Governance Group To review and assess the implications of all reported Urgent Safety Measures, which have been implemented at Portsmouth Hospitals Trust or during a PHT Sponsored study SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 4 of 12

5 6. PROCESS 6.1. PHT Hosted studies The process for PHT Hosted studies is illustrated in section 10.1 Upon dentifying a hazard to research participants requiring immediate action to protect their health or safety, which constitutes a change in study conduct and an urgent safety measure, the team member should, wherever possible first consult the protocol (for any explicit USM instructions), the Chief Investigator and the Sponsor of the study. Upon implementing an Urgent Safety Measure the study team must report the Urgent Safety Measure to the Sponsor by following instructions set out in the study protocol. Where there are no instructions the investigator should document all decisions and notify the Chief Investigator and Sponsor s research office using templates specified for PHT Sponsored studies published on:// All urgent safety measures implemented at the Portsmouth Hospitals NHS Trust should be notified to and recorded by the Research Office PHT Sponsored studies The process for PHT Sponsored studies is illustrated in section 10.2 Upon identifying a hazard to research participants, requiring immediate action to protect their health and safety, which constitutes a change in study conduct and an urgent safety measure, the team member should: Report the hazard and measures taken immediately to the Chief Investigator. Where the Chief Investigator is not available it must be reported to another delegated person or appropriate deputy Document the hazard and any actions taken on the Urgent Safety Measures (USM) Assessment, Record and Reporting Form. Upon notice of an implemented USM or a hazard that requires Urgent Safety Measures the Chief Investigator or delegated person should: Immediately Telephone the MHRA clinical trials unit to discuss the issue with an MHRA medical assessor (CTIMPS only). Contact details are provided in the table below. In practice this will ideally be done in parallel to identifying the necessary corrective and preventative measures required and discussions with the medical assessor may inform these actions. Telephone the Research Office to notify the Sponsor of all decisions/actions taken Document all decisions taken and their assessment of the impact, on the USM Assessment, Record and Reporting Form Within 24 hours of Telephone Notification or Fax the USM Assessment, Record & Reporting Form to the Research Office As soon as possible but in all cases within 3 days Notify the REC in writing (all studies) Notify the MHRA in writing (CTIMPS only), Notify any other sites and all local study team personnel SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 5 of 12

6 NOTE: Timelines exist except where a disease is (a) pandemic and (b) a serious risk or potentially serious risk to human health): Written notifications (within 3 days) should be made using a substantial amendment form. For CTIMPs the European Commission form, available on the EudraCT: European Clinical Trials website, must be used. The form should be signed by the named applicant (usually the Chief Investigator) and a single hard copy of the relevant form should be submitted to the Research Office, the MHRA and the REC, together with all relevant enclosures. For all Non-CTIMPS, the NRES Notice of Substantial Amendment, form should be used. The completed Notice of Substantial Amendment form should be either signed in ink by the Chief Investigator or authorised using electronic authorisation via the Integrated Research Application System (IRAS; Access to the form is enabled in IRAS when the submission history for the REC form shows there is a completed version of the initial application). A single hard copy of the form should be submitted to the REC, together with all relevant enclosures. In all cases forms should be sent with a covering letter detailing The urgent safety measure taken and date of implementation The reason for taking it The medical assessor contacted at the MHRA (where applicable) Any supporting documentation Written notifications must be sent to: 1) MHRA (where applicable) via marked Urgent Safety Measure and posted on a disk as PDF documents to the address provided below 2) The main REC that approved the study, via and post Copies of all correspondence should be filed in the TMF and sent to the Research Office on behalf of the Sponsor. Contact details: Chief Investigator Sponsor Contact details should be present within the site file For PHT Sponsored studies the research office should be contacted and a confirmation of receipt should be obtained. The office can be contacted via the following means: Telephone: Fax: Please write in the subject box Notice of Urgent Safety Measure MHRA Telephone: Post: Information Processing Unit, Area 6, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ REC This should be to the main REC that approved your study and will differ from study to study. If you are unsure please contact the Research Office. SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 6 of 12

7 6.3. Temporary halt of a trial: If the Chief Investigator and Sponsor decide that the hazard necessitates a temporary halt to the study, the Chief Investigator must notify the Research office, Main REC and MHRA within 15 days of the halt. This may be included on the same substantial amendment form as the notification of the urgent safety measure if appropriate. Notice of a temporary halt should make clear what specifically has been halted, (i.e. recruitment, or an interruption of the treatment of patients currently on the study) and the reasons for all decisions made Re-starting the trial: The Chief Investigator and Sponsor may decide to re-start the study, if it has been shown safe to do so. This should be done by submitting a substantial amendment to the Research Office, Main REC and MHRA (where applicable), including supporting evidence that it is now safe to resume the study. All approvals and permissions should be secured prior to implantation Study termination: If the Chief investigator and Sponsor decide not to re-start the temporarily halted study, the Chief investigator should submit an End of Trial declaration form and submit this to the REC and MHRA (where applicable) providing the reason why. This should be done within 15 days of the decision being made. 6.6 Research Office Procedure On receiving a telephone notice of an urgent safety measure Research Office staff should: Instruct the caller to notify the Chief Investigator (where not the CI) and provide them with an Urgent Safety Measures Assessment, Record & Reporting Form. Select the Urgent Safety Measures Tracker Sheet in the Templates folder on the shared G drive and record details of the telephone call Immediately notify the Director of Research or the Research Manager. Should both be unavailable an appropriate senior member of staff should be notified (for example the Trust Lead Research Nurse or Facilitator). Follow the tracker sheet and record all actions Record the USM and 3 day clock time on the office White board Create a departmental holding file containing the completed tracker sheet with location details of the electronic copy The Senior Manager will contact the Chief Investigator to discuss actions taken and check their compliance with the procedures outlined in section 6.2, recording all actions on the tracker sheet Where there is uncertainty with regards to any urgent safety measures required an Independent Medical Assessor will be contacted immediately. This person will usually be determined by the Research Director, Chief Investigator, Medical Director, Chair of the study Data Safety Monitoring Committee or in rare cases the Principal Investigator SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 7 of 12

8 7. TRAINING REQUIREMENTS All research staff should be trained in this procedure. Evidence of training shall be required for PHT sponsored CTIMP studies and Research Office staff. The Research Dept will endeavour to notify staff of SOP developments that may be relevant to them. Updates on SOPs will feature in research bulletins and communications. It is the responsibility of all research active staff to ensure that they read the Issued updates that may be relevant to them. When a new SOP is authorised, or when an existing SOP is revised, self directed training must be carried out by all staff to which the SOP is relevant and this training documented in their training record. A study specific SOP training plan will be developed for investigators on high risk PHT Sponsored studies. Staff should take time to read and fully understand the SOP and relevant documents, ensuring that they are able to implement the SOP when required. If clarification is needed then the trainee should approach their line manager and the SOP Controller who will arrange additional training. All staff should complete their training prior to the published implementation date. 8. REFERENCES AND ASSOCIATED DOCUMENTATION PHT/RDSOP/002: Standard Operating Procedure for Reporting Serious Breaches in Clinical Research Medicines for Human Use (Clinical Trials) Regulations 2004: SI 2004/1031 EudraCT: European Clinical Trials website (accessed 04 January 2011) National Research Ethics Service notice of substantial amendments documentation for CTIMPs and non-ctimps (accessed 04 January 2011) MHRA (Medical devices) (accessed 04 January 2011) 9. VERSION HISTORY LOG This area should detail the version history for this document. It should detail the key elements of the changes to the versions. Version Date Implemented Details of Significant Changes /07/2012 N/A /04/2016 Additional information regarding SOP training added SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 8 of 12

9 10. APPENDICES Hosted study flowchart Hosted study flowchart Immediate hazard and risk to patient s health or safety is identified at PHT Investigator notifies the Chief investigator and Sponsor immediately and follows their guidance Hazard, decisions & measures taken are documented PHT USM Record Form may be used if no template is provided by the Sponsor Urgent Safety Measure is implemented Investigator notifies the Sponsor immediately and follows their guidance copying all correspondence to the PHT Research Office The Research Office The research office should be contacted & confirmation of receipt obtained. The office contact details are as follows: Telephone: Fax: SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 9 of 12

10 10.2. PHT Sponsored study flowchart PHT Sponsored study flowchart Immediate risk to patient s health or safety is identified. Chief Investigator is contacted immediately Hazard is assessed and Urgent Safety Measure(s) implemented Hazard, decisions & measures taken are documented PHT USM Record Form to be used Chief Investigator immediately notifies the Research Office by telephone and contacts the MHRA Clinical Trials Unit for a safety assessment of any CTIMP Chief Investigator faxes or s USM Record Form to Research Office, within 24hours. CI submits written notification via a substantial amendment to the MHRA (if applicable) & REC copying Research Office within 3 days detailing: 1- The urgent safety measure taken 2- The reason for taking it 3- The medical assessor contacted at the MHRA (if applicable) 4- Any supporting documentation This may include the decision to temporarily halt the study. The Research Office The research office should be contacted & confirmation of receipt obtained. The office contact details are as follows: Telephone: Fax: MHRA This should be sent via to marked Urgent Safety Measure and posted on a CD as PDF documents to Information Processing Unit, Area 6, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ. REC This should be sent via and post. The REC will differ from trial to trial and the correct contact details will be on the Ethics approval letter SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 10 of 12

11 10.3. Training Record CONFIRMATION OF SOP TRAINING RECORD A copy of this record may be kept in your personal training file to confirm your training in a specific SOP. The research department or your line manager may request copies to verify your training. If required by a study Sponsor a record may also need to be kept in the Trial Master Files (TMF) or Investigator Site Files (ISF). SOP Details: To be completed by the SOP Controller Title of SOP Reference Number Reporting Urgent Safety Measures in Clinical Research PHT/RDSOP/006 Version v Apr 2016 Issue Date 07 April 2016 Implementation Date 07 April 2016 Personnel Details Name Job Title & Research Role Date of Training Nature of Training Self Directed/Delivered by etc Records of any meetings to clarify details in SOP Signatures I confirm that I have read and consider myself to be sufficiently trained in the above Standard Operating Procedure with regards to my individual roles and responsibilities Signature of Trainee Date I confirm training in the above SOP was delivered as recorded above and that the trainee may be considered sufficiently trained in their roles and responsibilities SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 11 of 12

12 Signature of Trainer Date. Additional Notes & Signatures Signature of Trainer (where appropriate) I confirm training in the above SOP was delivered as recorded above and that the trainee may be considered sufficiently trained in their roles and responsibilities Signature of Trainer Date. SOP for Reporting Urgent Safety Measures in Clinical Research, v Apr 2016 Page 12 of 12

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