Standard Operating Procedure for Managing Subjects During Weekends and Holidays in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/141/2025 |
| Supersedes | SOP/BA-BE/141/2022 |
| 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 the procedures and staffing responsibilities required to manage study subjects during weekends and public holidays, ensuring uninterrupted monitoring, subject comfort, and protocol compliance throughout the BA/BE study period.
2. Scope
This SOP applies to all clinical studies conducted at BA/BE units that involve overnight or extended stays of study subjects over weekends or holidays, including fed/fasted
studies, crossover studies, and studies involving extended washout periods.
3. Responsibilities
- Study Coordinator: Develops and circulates the weekend duty plan and subject activity schedules.
- Medical Officer: Remains on call or on site for emergency evaluations.
- Nursing Staff: Provides round-the-clock care and routine monitoring.
- Security/Support Staff: Ensures safety, comfort, and logistics for subjects over the non-working days.
4. Accountability
The Clinical Operations Manager is accountable for ensuring that weekend and holiday subject management plans are pre-approved, adequately staffed, and executed without deviation from the study protocol or GCP guidelines.
5. Procedure
5.1 Advance Planning
- Identify upcoming weekends and holidays during study planning.
- Include these dates in the Clinical Activity Calendar (Annexure-1) and ensure subject scheduling aligns accordingly.
- Prepare a staffing plan and duty roster at least one week in advance, covering all shifts.
- Obtain approvals from the Clinical Operations Manager and Principal Investigator.
5.2 Subject Briefing
- All enrolled subjects should be informed about weekend/holiday stay requirements during informed consent and again at pre-dosing briefing.
- Clearly explain:
- Activity schedule
- Meal timings
- Safety monitoring procedures
- Restrictions on movement and mobile device use, if applicable
- Provide emergency contact numbers and available medical support information.
5.3 Clinical Staffing and Coverage
- Ensure minimum staffing levels as follows:
- 1 Medical Officer on site/on-call per 20 subjects
- 2 Nurses per 25 subjects (1 per shift)
- Support staff (housekeeping/security) as per standard duty cycle
- Use Annexure-2: Weekend/Holiday Duty Roster to record shifts and assignments.
5.4 Subject Monitoring and Logs
- Continue all scheduled assessments as per protocol (e.g., vitals, sample collection).
- Record observations in:
- Annexure-3: Daily Subject Monitoring Log
- Annexure-4: Adverse Event Monitoring Log
- Maintain a dedicated Incident Log (Annexure-5) for any deviations, subject complaints, or medical events.
5.5 Meals, Hygiene and Recreational Support
- Ensure availability of food as per fed/fasted study design and dietary SOPs.
- Maintain sanitation, bed hygiene, and facility cleanliness as per SOP/BA-BE/78/2025.
- Allow non-disruptive recreational activities (e.g., reading, indoor games) within study restrictions.
5.6 Emergency Preparedness
- Ensure the on-site emergency medical kit is replenished and accessible.
- Verify ambulance readiness and emergency contact numbers at nursing station.
- Rehearse roles in case of:
- Subject collapse
- Fire alarm
- Adverse reaction requiring hospitalization
5.7 Documentation and Handover
- Each shift must document a handover note with subject status and pending tasks.
- All weekend and holiday logs must be filed within the subject folder and the master TMF.
- Conduct a post-holiday team debrief and file the summary in Annexure-6: Weekend/Holiday Management Report.
6. Abbreviations
- BA/BE: Bioavailability/Bioequivalence
- PI: Principal Investigator
- TMF: Trial Master File
- CRF: Case Report Form
7. Documents
- Clinical Activity Calendar – Annexure-1
- Weekend/Holiday Duty Roster – Annexure-2
- Daily Subject Monitoring Log – Annexure-3
- Adverse Event Monitoring Log – Annexure-4
- Weekend Incident Log – Annexure-5
- Weekend/Holiday Management Report – Annexure-6
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules, India
- WHO GCP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Clinical Activity Calendar
| Date | Activity | Staff Assigned | Remarks |
|---|---|---|---|
| 20/04/2025 | Fasting Sample Collection | Phlebotomist A | 6:30 AM |
Annexure-2: Weekend/Holiday Duty Roster
| Staff Name | Role | Shift Timing | Contact |
|---|---|---|---|
| Rajesh Kumar | Nurse | 07:00–15:00 | Ext 101 |
Annexure-3: Daily Subject Monitoring Log
| Subject ID | Date | Vitals | Symptoms | Remarks |
|---|---|---|---|---|
| SUB012 | 20/04/2025 | Normal | None | Stable |
Annexure-4: Adverse Event Monitoring Log
| Subject ID | Date | Event | Severity | Action Taken |
|---|---|---|---|---|
| SUB009 | 20/04/2025 | Headache | Mild | Paracetamol |
Annexure-5: Weekend Incident Log
| Date | Time | Description | Staff Involved | Resolution |
|---|---|---|---|---|
| 20/04/2025 | 21:00 | Subject requested early exit | Coordinator Ravi | Convinced to stay |
Annexure-6: Weekend/Holiday Management Report
| Date Range | Total Subjects | Incidents | Medical Events | Summary |
|---|---|---|---|---|
| 19–21/04/2025 | 36 | 1 | 0 | No serious deviations |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP release | New requirement | QA Head |
| 17/04/2025 | 2.0 | Expanded monitoring logs and annexures | GCP Audit Readiness | QA Head |