Standard Operating Procedure for Use of Case Record Forms (CRFs) in Clinical Phase of BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/090/2025
Supersedes	SOP/BA-BE/090/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standardized process for the use of Case Record Forms (CRFs) during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies, ensuring complete, accurate, and compliant documentation of clinical trial data.

2. Scope

This SOP applies to all personnel involved in the preparation, handling, completion, verification, and archival of CRFs during the clinical phase of BA/BE studies at the study site.

3. Responsibilities

• Clinical Research Coordinator (CRC): Ensures CRFs are correctly completed, signed, and maintained.
• Principal Investigator (PI): Reviews and verifies CRF data and signs off where applicable.
• Data Entry Operator: Inputs CRF data into electronic systems (if applicable) and reports discrepancies.
• QA Officer: Periodically audits CRFs for completeness and compliance.

4. Accountability

The Study Director is accountable for ensuring the CRFs reflect accurate source data and that any changes are properly documented and traceable.

5. Procedure

5.1 CRF Preparation and Design

1. Prepare protocol-specific CRFs including:
   • Demographic data
   • Informed consent confirmation
   • Dosing information
   • Vital signs, AEs, lab assessments
   • Sample collection schedule
2. Use printed CRFs or validated electronic CRFs (eCRFs) approved by QA and PI.

5.2 Distribution and Labeling

1. Each CRF must be assigned a unique subject ID and study code.
2. Maintain a CRF inventory log as per Annexure-1.

5.3 Data Entry and Documentation

1. Only authorized staff may make entries using black or blue ink.
2. All entries must be legible, dated, and signed by the data recorder.
3. For corrections:
   • Strike through the error with a single line
   • Write the correct data nearby
   • Date and initial the correction (no overwriting)
4. Do not leave any data fields blank. Use “NA” where applicable.

5.4 Review and Verification

1. PI or designee must review CRFs for each subject after clinical phase completion.
2. Sign the CRF review page (Annexure-2).

5.5 Data Entry and Discrepancy Management (If eCRF Used)

1. Data entry operator enters data from paper CRFs into eCRF system, if applicable.
2. All discrepancies flagged in the system must be reviewed and resolved by CRC and PI.

5.6 Archiving and Confidentiality

1. Store CRFs securely in locked file cabinets or controlled access servers.
2. Maintain records for a minimum of 5 years post-study or as per sponsor agreement.

6. Abbreviations

• CRF: Case Record Form
• eCRF: Electronic Case Record Form
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• QA: Quality Assurance
• AE: Adverse Event

7. Documents

1. CRF Inventory Log – Annexure-1
2. CRF Review & Verification Sheet – Annexure-2
3. CRF Correction Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CRF Inventory Log

Subject ID	CRF Issued Date	Issued By	CRF Status
VOL-090	16/04/2025	Sunita Reddy	Completed

Annexure-2: CRF Review & Verification Sheet

Subject ID	Reviewed By (PI)	Date	Remarks
VOL-090	Dr. Arvind Shah	17/04/2025	Verified and signed

Annexure-3: CRF Correction Log

Date	Subject ID	Field Corrected	Original Entry	Corrected Entry	Corrected By
17/04/2025	VOL-090	Weight	68.5	63.5	Ravi Nair

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP Release	New SOP	QA Head
17/04/2025	2.0	Added Annexures and clarification on CRF corrections	Audit Finding Resolution	QA Head