Controlled 

Document 

-­ 

do 

not 

download/save/print/photocopy

Cancer 

Clinical 

Trials 

Centre Standard 

Operating 

Procedure SOP  

No.: 37

Title: Source  

Data  

&  

Case  

Report  

Forms

Current  

Version  

No.: 4.1 Reviewed  

&  

Endorsed  

by  

STH  

Research: 07/03/2016 Approved: 15/03/2016

Effective  

Date: 24/11/2017

SOP  

Version  

History

Reviewed No  

Changes

Approved

Effective  

Date

1.0

12/12/2005

01/02/2006

31/01/2008

2.0

24/12/2007

01/02/2008

13/01/2011

3.0

21/05/2010

14/01/2011

28/02/2015

4.0

13/01/2015

01/03/2015

17/04/2016

4.1

15/03/2016

24/11/2017

Version

Ended

CCTC  

SOP  

Front  

Cover  

v4.0  

  

06/10/2017

SOP - Source Data & Case Report Forms Definitions (ICH GCP Guidelines July 2002 CPMP/ICH/135/95) Source Data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). Source Documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). Case Report Form (CRF) A printed, optical or electronic document designed to record all of the protocol required information to be reported to the Sponsor on each trial subject. The CRF contains information about:  Patient demographics  Study interventions  Administration of the study treatments (if applicable)  Study procedures  Outcome of assessments/tests  Adverse events Only data required by the protocol and any amendments should be recorded in the CRF. The contents of a CRF are confidential and should not contain patient identifying information. The CRF and its contents are the property of the Sponsor of the study. The data collected in the CRF is used directly as the basis for the trial report and any publications, as well as making up part of the data for the IMP regulatory approvals. SOP 37 – Source Data & CRF v4.1 Finalised: 19.01.2016 Page 1 of 4

The Sponsor (including trial monitors/CRAs) and Auditors/Regulatory authorities must be given access to the CRF on request. Source Data Collection All source data documents for Cancer Clinical Trial Centre (CCTC) studies are kept within the  patients’  medical  records  (hard  copy  and  electronic).  The  hard  copy  Sheffield  Teaching   Hospital NHS Foundation Trust (STH) medical  records  should  contain  a  ‘research  section’   that contains documents relating only to the study. To assist in the collection of source data, a document, checklist or template may be used, on which trial specific data as specified by the protocol and CRF is recorded. Such documents  are  known  as  ‘proformas’. Proformas are source data and are to be used in conjunction with the rest of the medical notes. Proformas are usually but not exclusively kept within the STH medical notes. They may be kept in a study working file until the end of the study, when they will be filed in the medical notes. Proformas are produced by the study team (Research Nurse, Data Manager and Research Co-ordinator). The team member who produces or updates a proforma should ensure the document is correctly version controlled. It should be proof read and signed off by a relevant Data Manager and a Research Nurse. Proformas should be reviewed and amended accordingly in the event of protocol amendments. If agreed with the Sponsor, CRFs may be photocopied and used as the proforma for a trial. Proformas are required to be signed and dated by the research team member and/or Investigator who has completed the document. Toxicity sheets may be used by clinicians to collect adverse event source data. These may be customised by the research team to be trial specific and are also version controlled. In accordance with the protocol, AE causality should be documented in the source data, either in the clinical notes or on a relevant proforma, and signed off by the PI or CoInvestigator. Causality assessment should be checked for consistency by the relevant Data Manager. Research Nurses should complete patient eligibility checklists. Confirmation of eligibility should be documented by the Investigator. The Patient Information Sheet and Consent Form version and date completed by the patient at the time of trial entry (and re-consent where applicable) should also be documented in the source data, either in the clinical notes or on a relevant proforma. SOP 37 – Source Data & CRF v4.1 Finalised: 19.01.2016 Page 2 of 4

Each  patient’s willingness to continue participation in the study should be re-confirmed by the Principal Investigator (or appropriate delegate) at every study visit. It is advised to document this procedure in the source data, either in the clinical notes and/or study proformas. CRF Completion The delegation of responsibility of CRF completion (including data entries, corrections and sign off of pages) by the Investigator should be documented on the study delegation/responsibility log. Within the CCTC, this responsibility is usually delegated to the Data Manager. CRFs should be completed to a feasible timeframe according to the study patient visits, specifications of the study protocol and Sponsor CRF completion guidelines. Data to be collected at each patient visit and CRF completion timelines should be discussed and agreed at study set up/initiation meeting. The CCTC ‘Source  Data   Agreement’  document  should also be discussed and completed with the research team and Sponsor at study set up and initiation. The Sponsor should provide training and a manual for any eCRF applications used. It is good practice that more than one person is trained in access and navigation of an eCRF application, to provide cover for unexpected and planned absences. All data entered into a CRF should be accurate and easily verified against source data documents. Data on paper CRFs must be written clearly in black ballpoint pen. Corrections to data on paper CRFs should be made by crossing through the incorrect entry with a single line to ensure the original data remains legible. The correction must be initialled and dated. Correction fluid must not be used. The correct data should be entered at the side of the original data. The reason for the data correction will be indicated if this is a protocol requirement. Any unclear source data should be discussed with the relevant, qualified person before entering onto the CRF. Abbreviations should not be used, unless they are known to be acceptable.

SOP 37 – Source Data & CRF v4.1 Finalised: 19.01.2016 Page 3 of 4

All data fields should be completed without omissions or blank spaces. Data fields for which information cannot be provided will be completed with a relevant explanation such as not done, unknown (or ND, NK) as per guidelines if provided. Numerical fields should contain leading/ending zeros unless guidelines specify otherwise (for example 091.70kg). Unless otherwise agreed, laboratory values should be entered without conversion from printed/electronic reports. Laboratory results should have been reviewed by the appropriate clinician. The Investigator or delegate should sign off the CRF wherever indicated. The Data Manager (or delegate) will send CRFs to the Sponsor by the method agreed:  eCRF - data is generally submitted as soon as completed.  Fax - data  is  faxed  to  an  allocated  number.  A  ‘fax  send  report’  is  filed  with  CRF.    Post - the original wet-ink copy is sent by post and a copy is filed at site.  Collection - a study monitor attends the site, carries out Source Data Verification (SDV) and collects completed forms. CRFs should be kept on site in a safe and secure location throughout the duration of the study and later archived as per protocol guidelines or CCTC SOP 17 Archiving. References STH Research Department A124 SOP Version 1.6 - Maintaining the CRF for externally sponsored studies (04 August 2009) ICH GCP Guidelines July 2002 CPMP/ICH/135/95 CCTC Source Data Agreement

SOP 37 – Source Data & CRF v4.1 Finalised: 19.01.2016 Page 4 of 4