Office of Human Research
Page Title

SOP No.: 701   CASE REPORT FORMS

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to:  All CRFs that are developed in conjunction with clinical protocols for the Food and Drug Administration (FDA)-regulated human subject research conducted by Investigators within Thomas Jefferson University’s own facility.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

1. PURPOSE

This procedure describes the process for designing, reviewing, approving, and revising case report forms (CRFs) that will be used to collect protocol-specified data during a clinical study intended to collect safety and/or efficacy data on an unapproved use of a drug, biologic or medical device (the investigational product).

2. GENERAL INSTRUCTIONS

  1. The Author of the CRF is responsible for preparing the initial draft CRF, forwarding the draft to all appropriate key personnel for review, and distributing final approved CRFs to all Investigators at all participating sites.
  2. The Investigator may forward final CRFs to the FDA with the protocol as part of a regulatory submission, and to any other regulatory bodies, for their review, if it is deemed appropriate and necessary to request such review.
  3. The Investigator and all participating site Investigators and their designees are responsible for completing the CRF for each participant as required in the protocol and as instructed during the study initiation visit.
  4. The Investigator will ensure that all key personnel at participating investigative sites are trained on the proper completion of all CRF, referring to the requirements in SOP 502, Clinical Research Data Management and SOP

3. SPECIFIC PROCEDURES

3.1 Designing Case Report Forms

  1. The Investigator will determine who will design the CRF (the Author).
  2. Because the CRF is a controlled document, the Author will follow the general procedures in SOP 102, Document Development and Change Control to design, review and approve the CRF.
  3. To design CRF, the Author should schedule a CRF design meeting to seek input from experts, including statisticians, and database developers (typically the same group that designed the study protocol) as well as data entry personnel.
  4. The designers of the CRF will use the study protocol for identifying specific data points that will be needed for the planned analyses.
  5. The designers also will determine whether the CRF format is paper-based, electronic (e.g., on a computer or electronic diary), or Internet-based, and ensure that the content review also incorporates format review by additional experts as appropriate.
  6. The Author should complete a Document Control Form, for circulating with the draft CRF during its review and approval (See SOP 102 Attachment A).
  7. Based on the CRF design meeting input, the Author should design the draft CRF, identify the draft CRF as "Draft [date]" in the Document Number section of the form and in the Footer of the draft CRF and begin the review and approval process.

3.2 CRF Review and Approval

  1. The Author will circulate the draft CRF for review and comments by all relevant parties, to ensure that the proposed CRF captures all necessary participant information, and secure the signature/review date of all reviewers on the form.
  2. The Author will revise the CRF per initial review process. He/She will update CRF version numbers on the CRF and Document Control Form as necessary and repeat the review process until all appropriate changes have been incorporated.
  3. The Author will have the final draft CRF approved by the review group, with Signatures and Approval Dates indicated in the appropriate areas of the Document Control Form.
  4. Before final CRF approval, the Author will validate the CRF by using contrived data based on the protocol to ensure CRF completion is clear, consistent and captures all data points.
  5. Once approved, the Author will give the CRF a final version number and effective date for the CRF in the Footer.
  6. The Author will attach a clean copy of the final CRF to the clinical protocol.
  7. CRFs may accompany their respective protocols throughout the regulatory review and approval processes, as appropriate (e.g., FDA, National Institutes of Health).
  8. The Author will make, review and approve any subsequent changes to the CRF as described in SOP 102 for controlled documents.
  9. The Author will document subsequent changes on the CRF on that document's Table of Modifications.
  10. When protocol amendments are in process, the author will revise the CRF to reflect the changes to the protocol and include the revised CRF in the protocol amendment review, approval and documentation process.
  11. Approved CRF and subsequent revisions will be retained as described in SOP 503, Documentation and Records Retention.

3.3 CRF Completion Guidelines

3.3.1 Site CRF Completion Tasks

  1. The Investigator will train the site personnel on the following specific CRF completion tasks:
  2. Ensure that data for the CRF are transcribed in a timely manner from the source documentation
  3. Record all participant data and information in black ballpoint pen on paper CRF
  4. Complete all fields in the CRF according to protocol specifications and site initiation training
  5. Correct errors by striking through the error with a single straight line, making the correction and then dating and initialing the correction
  6. Ensure the original entry is not obliterated by the correction and if necessary, note an explanation or clarification in the CRF margin
  7. If using remote data entry or other electronic systems, train the site personnel on the use of those systems

3.3.2 General Requirements

  1. The Monitor will review the first sets of completed CRF for completeness and accuracy, asking another designated individual to repeat the review for verification, as a way of assessing whether site personnel are correctly completing the CRF.
  2. An On-Site Query Report Form will be used by the monitor and the investigative site personnel to use as a tool for maintaining an audit trail of clarifications and corrections for a single participant.
  3. The Investigator will ensure that the participating sites keep the Subject Data Clarification Forms with other study records in the appropriate participant's study files.
  4. The Monitor will assess CRF completion status at each monitoring visit that is conducted during the course of the study, and at the closeout visit when the study is completed or otherwise suspended or terminated.
  5. At the conclusion of the study, all sites will ensure that CRF originals and copies are retained according to regulatory and Investigator requirements, in both the Investigator's Regulatory Master File and the site's participant files.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.23

IND Content and Format

21 CFR 312.62

Investigator recordkeeping and record retention

21 CFR 812.25

Investigational plan

21 CFR 814.140

Records

ICH E6, section 2.10

The principles of ICH GCP

ICH E6, section 4.9

Records and reports

ICH E6, section 5.1

Quality assurance and quality control

ICH E6, section 5.4

Trial design

ICH E6, section 5.5

Trial management, data handling and record keeping

ICH E6, section 5.23

Multicentre trials

5. REFERENCES TO OTHER APPLICABLE SOPs

102

Document development and change control

301

Clinical protocol development, implementation and compliance

302

Clinical protocol amendments

402

Initiation visit and site training

503

Documentation and records retention

504

Routine monitoring visits

505

Study closeout visit

702

Clinical research data management

703

Use of electronic data systems

6. ATTACHMENTS

A. On-Site Query Report Form

7. DEFINITIONS AND GLOSSARY

The following definitions from the International Conference on Harmonisation, Good Clinical Practice: Consolidated Guideline, apply to this SOP.

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.

Confidentiality:  Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

Documentation:  All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Documents:  Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Quality Assurance (QA):  All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s).

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 and complete, 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).

 

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