SOP Guide for Pharma

BA-BE Studies: SOP for Weekend and Holiday Subject Management – V 2.0

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BA-BE Studies: SOP for Weekend and Holiday Subject Management – V 2.0

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.

See also  BA-BE Studies: SOP for Ensuring Compliance with Schedule Y Clinical Requirements - V 2.0

5. Procedure

5.1 Advance Planning

  1. Identify upcoming weekends and holidays during study planning.
  2. Include these dates in the Clinical Activity Calendar (Annexure-1) and ensure subject scheduling aligns accordingly.
  3. Prepare a staffing plan and duty roster at least one week in advance, covering all shifts.
  4. Obtain approvals from the Clinical Operations Manager and Principal Investigator.

5.2 Subject Briefing

  1. All enrolled subjects should be informed about weekend/holiday stay requirements during informed consent and again at pre-dosing briefing.
  2. Clearly explain:
    • Activity schedule
    • Meal timings
    • Safety monitoring procedures
    • Restrictions on movement and mobile device use, if applicable
  3. Provide emergency contact numbers and available medical support information.

5.3 Clinical Staffing and Coverage

  1. 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
  2. Use Annexure-2: Weekend/Holiday Duty Roster to record shifts and assignments.

5.4 Subject Monitoring and Logs

  1. Continue all scheduled assessments as per protocol (e.g., vitals, sample collection).
  2. Record observations in:
    • Annexure-3: Daily Subject Monitoring Log
    • Annexure-4: Adverse Event Monitoring Log
  3. Maintain a dedicated Incident Log (Annexure-5) for any deviations, subject complaints, or medical events.
See also  BA-BE Studies: SOP for Handling Confidentiality Agreements with Study Sites - V 2.0

5.5 Meals, Hygiene and Recreational Support

  1. Ensure availability of food as per fed/fasted study design and dietary SOPs.
  2. Maintain sanitation, bed hygiene, and facility cleanliness as per SOP/BA-BE/78/2025.
  3. Allow non-disruptive recreational activities (e.g., reading, indoor games) within study restrictions.

5.6 Emergency Preparedness

  1. Ensure the on-site emergency medical kit is replenished and accessible.
  2. Verify ambulance readiness and emergency contact numbers at nursing station.
  3. Rehearse roles in case of:
    • Subject collapse
    • Fire alarm
    • Adverse reaction requiring hospitalization

5.7 Documentation and Handover

  1. Each shift must document a handover note with subject status and pending tasks.
  2. All weekend and holiday logs must be filed within the subject folder and the master TMF.
  3. 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

  1. Clinical Activity Calendar – Annexure-1
  2. Weekend/Holiday Duty Roster – Annexure-2
  3. Daily Subject Monitoring Log – Annexure-3
  4. Adverse Event Monitoring Log – Annexure-4
  5. Weekend Incident Log – Annexure-5
  6. Weekend/Holiday Management Report – Annexure-6
See also  BA-BE Studies: SOP for Conducting Mock Runs for BA/BE - V 2.0

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
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