Document Title: Study Data SOP (CRFs and Source Data)

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1 Document Title: Study Data SOP (CRFs and Source Data) Document Number: SOP047 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager, Research Officers R&D Administration Manager Research and Development Research and Development NHS Staff Trust-Wide Review due: 17 February 2018 THIS IS A CONTROLLED DOCUMENT Whilst this document may be printed, the electronic version maintained on the Trust s Intranet is the controlled copy. Any printed copies of this document are not controlled. Papworth Hospital NHS Foundation Trust. Not to be reproduced without written permission. Key Points of this Document This document sets out the procedures to be followed by all Papworth Staff who record data for the purpose of research. It aims to provide clear guidance on how data collected in the course of research should be documented and how records should be stored to ensure compliance with the Trust s policies. 8 Page 1 of 6

2 1 Purpose and Content a. This document defines the Trust s research procedures for the recording of study related data in Research Studies and Clinical Trials at Papworth Hospital. This includes the completion of Case Report Forms (CRFs), both electronic and paper, and the recording of source data in medical records. The case report form is a paper or electronic questionnaire specifically used in clinical trial research to collect the information as required by the protocol. b. The document clarifies the requirements for maintaining accurate and thorough records as described in Good Clinical Practice (GCP: a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected ). c. The document aims to provide clear guidance on how research data should be collected and stored so as to comply with the Trust s policies on Information Governance and Patient confidentiality. d. The subsequent use and analysis of research study data is outside the scope of this SOP and is described in SOP 021: Trial Closure and End of Trial Reporting. e. The monitoring of study data to ensure its validity of the data is outside the scope of this SOP and is described in SOP 016: Monitoring Papworth Sponsored Studies. 2 Roles & Responsibilities a. This Policy applies to all personnel that are conducting research at the Trust. b. Staff recording study data must comply with the requirements set out in section 4 c. The Principle Investigator must ensure that if their research staff is recording or handling study data, that they are trained and compliant with GCP procedures. Staff entering data in CRFs must be listed on the study delegation log. d. The responsibility for the completion of case report forms lies with the Principle Investigator. This may be delegated 8 Page 2 of 6

3 3 Policy a. This SOP is mandatory and, as per the Trust s Information Governance and Records Management framework, non-compliance with may result in disciplinary procedures. 4 Procedure 4.1 Case Report Forms (CRFs) a. The responsibility for completing the forms remains with the Principal Investigator. This can be delegated. The delegation of responsibility of this duty by the investigator should be documented on the Study Delegation Log/ Site Responsibility Log and only these Individuals may enter data in a CRF. b. The patient is identified by a study code and/or initials only on the CRF, the patient s full name should never appear. c. A Screening Log and Randomisation Log (if applicable) must be kept electronically by the Investigator, or designated research team member, listing the patients in the study. This must be updated regularly. They should consist of the patient s initials, study number and randomisation number / group (if applicable). These logs should be kept in a secure location and accessed only by authorised members of the study team. d. The CRF should be signed, when required, by the Principal Investigator or designee (as appropriate) to confirm that he/she believes they are complete and accurate. e. CRFs should be kept in a secure location during the course of the study and accessed only by authorised members of the study team, regulatory authorities and monitoring staff. CRFs should then be archived (Archiving SOP 011) when the study has finished in accordance with Trust Procedures and Sponsor requirements. 4.2 Source Data Documentation a. The hospital notes must be clearly labelled to indicate that a patient is participating in a trial. An alert sticker is affixed to the outside front cover of the case notes. Details of the clinical trial should be inserted in the relevant section of the alert sheet. A study specific label or hand written note detailing the trial is added to the communication or history sheet. R&D are responsible for producing study specific labels for placing upon alert sheets within hospital notes. b. A copy of the signed consent form must be filed in the case notes. 8 Page 3 of 6

4 c. Where a copy of the REC approved GP letter (if appropriate for the study) has been sent to the GP, a copy should be filed in the notes unless other evidence that the GP is aware of the patient s participation exists. d. Source data is stored in accordance with Trust Procedures. 4.3 Data recording a. Source Data must be recorded at each study visit. CRFs must be completed in a timely fashion, i.e. during, or as soon as possible after, the study visit has been completed. CRFs are completed according to the specifications of each study. b. For clinical trials of investigational medicinal products further information should be documented within the patient s medical notes such as visit number, study number, which study procedures have been completed etc. This is advisable for all studies. c. All CRFs must be completed in accordance with the standards described in GCP guidelines. d. Method of documentation: Always use a ballpoint pen; the use of black ink is preferable. Ensure data entry is as complete as possible without omissions. If data are unavailable write, for example, unknown (UK), missing, test not done, etc as defined by CRF Completion Guidelines (if applicable). Avoid using the ambiguous phrase, not available. Where possible an explanation should be provided for the missing data. This should also be initialled and dated. Ensure all entries are accurate, legible and verifiable with the source data in the medical record e. For studies that are governed by MHRA authorisation all test reports (e.g. blood results, radiology reports, ECGs) must be signed and dated by the PI or designee in accordance with GCP. Any abnormalities must be noted and marked as either clinically significant or insignificant. Abnormal results should be recorded as an adverse event, depending upon their nature, and the appropriate action taken. f. Corrections should be made as follows: Cross out the incorrect entry with a single line so that the incorrect entry is legible. Never use correction fluid or obliterate entries made on the CRF. Enter the correct data. 8 Page 4 of 6

5 Initial and date the correction and, if appropriate, give an explanation of the correction. g. The procedure to be followed for the resolution of data queries should be agreed with the study sponsor and documented in the protocol. h. Laboratory values should be entered as they are without conversion from printed reports, even if in multi-centre study units of measurement differ from centre to centre, unless otherwise agreed in writing. 5 Risk Management / Liability / Monitoring & Audit a. The R&D SOP Committee will ensure that this SOP and any future changes to this document are adequately disseminated. b. The R&D Department will monitor adherence to this SOP via the routine audit and monitoring of individual clinical trials and the Trust s auditors will monitor this SOP as part of their audit of Research Governance. From time to time, the SOP may also be inspected by external regulatory agencies (e.g. Care Quality Commission, Medicines and Healthcare Regulatory Agency). c. In exceptional circumstances it might be necessary to deviate from this SOP for which written approval of the Senior R&D Manager should be gained before any action is taken. SOP deviations should be recorded including details of alternative procedures followed and filed in the Investigator and Sponsor Master File. d. The Research and Development Directorate is responsible for the ratification of this procedure. 8 Page 5 of 6

6 Further Document Information Approved by: Management/Clinical Directorate Group Approval date: (this version) Ratified by Board of Directors/ Committee of the Board of Directors: Date: This document supports: Standards and legislation Key related documents: Research and Development Directorate 17 th February 2015 STET N/A Medicines for Human Use (Clinical Trials) Regulations 2004 and all associated amendments. Research Governance Framework for Health and Social Care (2005) Trust Research Policy SOP011 Archiving of Research Studies SOP021 Trial Closure and End of Trial Reporting SOP016 Monitoring Papworth Sponsored Studies Equality Impact Assessment: Does this document impact on any of the following groups? If YES, state positive or negative, complete Equality Impact Assessment Form available in Disability Equality Scheme document DN192 and attach. Groups Disability Race Gender Age Sexual orientation Religious & belief Other Yes/No No No No No No No No Positive/Negative N/A N/A N/A N/A N/A N/A N/A Review date: February 2018 Version Control Version Date effective Valid to Approved by Date of approval th Feb th Feb 2014 RDD 10 th Feb th Mar 2015 Feb 2018 RDD 13 th March Page 6 of 6

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