TRIAL DATA

COLLECTION AND ENTRY

STANDARD OPERATING PROCEDURE NO / SOP07
DATE RATIFIED / Sep 2014
NEXT REVIEW DATE / Sep 2016

POLICY STATEMENT/KEY OBJECTIVES:

This SOP details the process for collection of trial data and the completion of Case Report Forms.

POLICY AUTHOR: Katie Glickman; Research Facilitator

BACKGROUND

In the International Conference of Harmonisation Good Clinical Practice (ICH GCP)guidelines, a Case Report Form (CRF) is defined as ‘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 trial sponsor/office issue guidance on how data should be recorded on the CRF. Investigators are required to comply with this guidance. Documentation of information in the CRF should be accurate, complete, legible and collected and submitted to the trial sponsor/office in a timely fashion. Compliance with the Data Protection Act, 1998 is mandatory. Patient identifiable information on the case report form (CRF) should not be disclosed to a third party, unless a patient has consented to this disclosure. In all correspondence the patient’s identity must be anonymised using their trial Identification code. The subject enrolment log in the trial investigator site file should be used to record each patient’s name and trial Identification code. CRFs should be stored securely in a locked cupboard, filing cabinet or office. CRFs must only be completed by authorised staff whose signature is included on the delegation log in the trial investigator site files and has been signed off by the Principal Investigator (PI) prior to patient/research staff interactions. See SOP 09 Roles, responsibilities and delegation of duties.

PURPOSE

This SOP details the process for completion of CRFs and the required data to be collected for the following studies within LCFT:

-CTIMPS

-Trust sponsored clinical trials

-Interventional studies

PROCEDURE

A sample CRF should be kept in the investigator site file along with superceded copies clearly marked as such. Where forms are downloaded from a trial website, a sample copy should be printed and filed in the trial investigator site file. CRFs should only be completed/corrected by individuals whose name, initials and signature appear on the delegation log. The trial sponsor/office may provide a delegation log for completion. At the patient visit, all data required by the protocol should be recorded in the study case report forms from the patient medical notes and the details of the research trial should be documented in the patient medical notes. Theseentries should be signed and dated in the trial documents. To facilitate the monitoring process, ensure that the following are recorded in the notes:

  • Patient eligibility, date of consent and date of randomisation/ enrolment
  • Dose and/or therapy modifications
  • Adverse events, concomitant medications, inter-current illnesses
  • All visits that subjects fail to attend, tests that are not conducted, examinations not performed
  • All withdrawals of enrolled subjects

Data recorded on the CRF that are derived from the subject’s medical notes should be consistent with the medical notes. Any discrepancies should be explained on the CRF or in the medical notes.

Data entry

Entries onto the CRF must comply with the instructions supplied by the trial sponsor/office. Unless otherwise instructed by the trial sponsor/office, all entries:

  • Must be legible
  • Written in black ink
  • If CRFs are printed on carbonless duplicated paper, ensure that a suitable separator is inserted
  • Never leave blank spaces. If data is not available write unknown, missing, test not done, as defined by the trial CRF completion guidelines.

Unless instructed otherwise by the trial sponsor/office, changes or corrections to the CRF should be made as follows:

  • Cross out the incorrect entry with a single line, ensuring that it is still visible
  • Enter the correct data, giving an explanation for the correction, if necessary
  • Initial and date the correction
  • Never use correction fluid
  • Write in black ink

Finalisation of the CRF

All source documents requiring a PI signature should be dated and signed on completion by the PI or other authorised personnel whose signature is included on the delegation log. Completed and signed CRFs should be returned within the timelines specified by the trial sponsor/office or within two weeks of the trial subject’s visit, whichever is the sooner, unless they are collected by the sponsor at monitoring visits and audit. A covering letter should be included with the completed CRFs and a copy kept in the trial investigator site file. A copy of all completed CRFs must be retained as part of the trial investigator site file; this may be in the form of electronic records. Copies of the medical notes and/or reports of investigations for trial subjects should only be kept with the CRF if requested by the trial sponsor/office.

Data queries

Data queries should be resolved, signed and dated and returned within the timelines specified by the trial sponsor/office or within two weeks. Any delays in responding to data queries should be reported to the trial sponsor/office. A copy of all data queries and responses to the trial sponsor/office should be kept with the CRF. Research teams experiencing any difficulties in completing data queries in a timely manner should inform the sponsor.

OTHER RELATED PROCEDURES, POLICIES, LEGISLATION OR GUIDANCE

ICH GCP

Research governance framework, 2nd edition 2005

EU Directive 2001/20/EC

GLOSSARY

Lancashire Care Foundation Trust (LCFT)

International Conference of Harmonisation Good Clinical Practice (ICH GCP)

Case Report Forms (CRFs)

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