in source data documentation, CRF/eCRF data entry, data verification, and clinical quality assurance during the conduct of BA/BE studies.

3. Responsibilities

• Study Nurse: Documents observations and procedures in real-time on source documents.
• Clinical Research Coordinator (CRC): Verifies completeness and consistency of source documents and performs CRF data entry.
• Principal Investigator (PI): Reviews and signs off on key clinical data and source-CRF correlation.
• QA Officer: Audits data trail from source to CRF and ensures ALCOA+ compliance.

4. Accountability

The Study Director is accountable for ensuring that all source documents and CRFs are handled according to applicable regulatory guidelines, and that data integrity is maintained throughout the clinical phase.

5. Procedure

5.1 Source Documentation

1. Use only approved source templates pre-printed with study ID, subject ID, and visit date.
2. Document the following at source:
   • Volunteer identity and informed consent status
   • Vital signs
   • Pre- and post-dose assessments
   • Adverse events
   • Dosing records
   • Sample collection times and personnel
3. All entries must be:
   • Legible
   • Signed and dated
   • Made in blue or black ink
4. Corrections must follow GCP standards: strike through, write correct entry, date and initial.

5.2 CRF Data Entry

1. Transfer data from source to CRFs after each study activity or at end of day.
2. Ensure that:
   • CRF data matches the source exactly
   • Blank fields are marked “NA”
   • Corrections follow SOP for CRF amendments
3. Document and explain any discrepancies using Annexure-1: Source-CRF Discrepancy Log.

5.3 Electronic Data Capture (eDC)

1. If using eCRFs, enter data directly into the validated system with individual login credentials.
2. Audit trails must remain intact and accessible for inspection.

5.4 Quality Control and Review

1. CRC must perform cross-checks of 100% of critical fields (e.g., date/time of dosing, AE records).
2. PI to review and sign off on CRFs and summaries (Annexure-2: CRF Verification Log).

5.5 Storage and Confidentiality

1. Store source documents in subject-wise files secured in a locked room with access logs.
2. Electronic source and CRFs must be password protected and regularly backed up.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRF: Case Report Form
• eCRF: Electronic Case Report Form
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available

7. Documents

1. Source-CRF Discrepancy Log – Annexure-1
2. CRF Verification Log – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• 21 CFR Part 11 – Electronic Records
• Schedule Y – Drugs and Cosmetics Rules

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Source-CRF Discrepancy Log

Date	Subject ID	Field	Source Value	CRF Value	Resolution	Reviewed By
17/04/2025	VOL-091	Pulse	78	87	Corrected in CRF	Dr. Arvind Shah

Annexure-2: CRF Verification Log

Subject ID	Date Reviewed	Reviewed By	Remarks
VOL-091	17/04/2025	Dr. Arvind Shah	Complete and accurate

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP	GCP Compliance	QA Head
17/04/2025	2.0	Added ALCOA+ reference, clarified eCRF and source reconciliation	Audit Observation	QA Head