Standard Operating Procedure for Review of Subject Recruitment Feasibility in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/037/2025 |
| Supersedes | SOP/BA-BE/037/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for reviewing and documenting the feasibility of recruiting healthy volunteers or study subjects for Bioavailability/Bioequivalence (BA/BE) studies in order to ensure timely completion of enrollment and avoid protocol deviations.
2. Scope
This SOP applies to all BA/BE studies planned by the organization or outsourced to CROs, and includes pre-study feasibility assessment, documentation, and monitoring of recruitment plans for healthy adult volunteers or special populations, if applicable.
3. Responsibilities
- Clinical Project Manager: Coordinates feasibility assessments and compiles the feasibility report.
- Site Coordinator/Investigator: Provides actual recruitment capability data based on past records.
- Regulatory Affairs: Assesses if any restrictions apply (e.g., ethics caps on enrollment).
- Medical Affairs: Reviews inclusion/exclusion criteria for practical applicability.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that a realistic and documented recruitment plan is in place before first subject screening is authorized.
5. Procedure
5.1 Initiation of Feasibility Assessment
- Initiate feasibility assessment during the protocol finalization phase or at least 4 weeks prior to planned study start.
- Use Annexure-1: Subject Recruitment Feasibility Questionnaire to collect site-specific information.
5.2 Data Collection Parameters
- Collect the following data from study sites:
- Historical enrollment data for similar BA/BE studies
- Average screening-to-enrollment ratio
- Volunteer pool database size
- Number of similar studies planned at the site during the same period
- Availability of healthy volunteers meeting protocol criteria
5.3 Feasibility Analysis and Risk Assessment
- Review the protocol to identify restrictive criteria (e.g., BMI, lab values, washout requirements).
- Conduct SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis for each site.
- Document analysis using Annexure-2: Site Recruitment Feasibility Summary.
5.4 Recruitment Strategy and Contingency Planning
- Define the following in the recruitment plan:
- Number of volunteers needed vs. site capacity
- Backup sites (if applicable)
- Contingency for screen failures and dropouts
- Communication materials (approved recruitment flyers, SMS templates)
- Capture in Annexure-3: Study Recruitment Plan Log.
5.5 Approval and Filing
- Ensure all annexures are completed and approved by the Clinical Project Manager.
- File in the Trial Master File (TMF) and make available for ethics and regulatory review, if requested.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- TMF: Trial Master File
- SWOT: Strengths, Weaknesses, Opportunities, Threats
7. Documents
- Subject Recruitment Feasibility Questionnaire – Annexure-1
- Site Recruitment Feasibility Summary – Annexure-2
- Study Recruitment Plan Log – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- EMA Clinical Trial Recruitment Guidance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Subject Recruitment Feasibility Questionnaire
| Question | Response |
|---|---|
| Size of healthy volunteer database? | 1200 active profiles |
| Previous BE study enrollments in 12 months? | 5 studies, average 80 subjects each |
Annexure-2: Site Recruitment Feasibility Summary
| Site Name | Strengths | Weaknesses | Opportunities | Threats |
|---|---|---|---|---|
| Alpha Research Centre | Large volunteer pool | Limited staff on weekends | High visibility via SMS | Competing study same month |
Annexure-3: Study Recruitment Plan Log
| Activity | Planned Date | Owner | Status |
|---|---|---|---|
| Flyer Approval from EC | 18/04/2025 | Regulatory | Pending |
| SMS Campaign Launch | 22/04/2025 | Site Coordinator | Scheduled |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | New feasibility assessment policy | QA Head |
| 17/04/2025 | 2.0 | Added SWOT analysis and SMS campaign planning | Recruitment optimization | QA Head |