SOP Guide for Pharma

BA-BE Studies: SOP for Daily Safety Monitoring Logs – V 2.0

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BA-BE Studies: SOP for Daily Safety Monitoring Logs – V 2.0

Standard Operating Procedure for Daily Safety Monitoring Logs in BA/BE Clinical Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/139/2025
Supersedes SOP/BA-BE/139/2022
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 recording and reviewing safety data on a daily basis for all subjects enrolled in BA/BE studies to ensure real-time monitoring, timely intervention, and regulatory compliance.

2. Scope

This SOP is applicable to all clinical trials conducted within the BA/BE unit involving human subjects, including fasted and fed studies, and is relevant to physicians, nurses,

coordinators, and QA personnel involved in safety data collection and review.

3. Responsibilities

  • Medical Officer: Reviews and signs off on all daily safety logs, initiates medical actions if needed.
  • Study Nurse: Records vital signs, clinical observations, and adverse events in the daily logs.
  • Clinical Coordinator: Ensures completeness and accuracy of daily entries.
  • QA Officer: Conducts random audits of the logs and verifies compliance during study monitoring visits.
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4. Accountability

The Principal Investigator is accountable for ensuring all daily safety monitoring logs are maintained accurately and reviewed regularly, with appropriate actions taken for any observed safety concerns.

5. Procedure

5.1 Preparation of Daily Monitoring Logs

  1. Before study commencement, the Clinical Coordinator shall prepare study-specific daily safety monitoring logs using the approved template (Annexure-1).
  2. Logs shall include fields for:
    • Subject ID, date, study period
    • Time-stamped vital sign entries (BP, HR, Temp, RR)
    • Clinical symptoms or observations
    • Medication given, if any
    • Remarks and investigator review section
  3. Print sufficient hard copies and store in binders marked by study period and subject sequence.

5.2 Recording Observations

  1. Study nurse records baseline safety data 30 minutes prior to dosing.
  2. Post-dose monitoring shall be conducted at:
    • 15 min, 30 min, 1 hr, and then hourly for 6 hours or as per protocol
  3. In case of any abnormal finding (e.g., BP > 140/90 mmHg, Temp > 38°C), escalate to Medical Officer for evaluation.
  4. Enter details immediately in the monitoring log and counter-sign once reviewed.

5.3 Investigator Review

  1. Medical Officer shall review all entries at end of the day and note:
    • Any clinically significant change in vital signs
    • Onset of adverse drug reactions (ADRs)
    • Actions taken (e.g., medication, hydration, withdrawal)
  2. Use Annexure-2: Investigator Daily Review Sheet to summarize safety findings per subject.
  3. Sign and date all reviewed pages with comments as necessary.
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5.4 Storage and Version Control

  1. Logs must be stored in chronological order in subject-wise folders within the Trial Master File.
  2. Each version of the template shall be identified using a version control number.
  3. Do not overwrite any original entries; strike through errors with a single line and sign/date corrections.

5.5 Quality Assurance Oversight

  1. QA team shall randomly review 10% of safety logs for:
    • Legibility, completeness, and corrections
    • Timeliness of documentation
    • Deviation from expected monitoring frequency
  2. Observations shall be documented in Annexure-3: QA Safety Log Review Report and shared with the PI for CAPA, if necessary.

5.6 Retention and Archival

  1. Completed logs shall be archived as per site SOPs and retained for at least 5 years post-study or as per regulatory requirement.
  2. Digitized copies may be maintained for backup with controlled access and audit trails.

6. Abbreviations

  • BP: Blood Pressure
  • HR: Heart Rate
  • RR: Respiratory Rate
  • QA: Quality Assurance
  • PI: Principal Investigator
  • TMF: Trial Master File
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7. Documents

  1. Daily Safety Monitoring Log Template – Annexure-1
  2. Investigator Daily Review Sheet – Annexure-2
  3. QA Safety Log Review Report – Annexure-3

8. References

  • ICH E6(R2) – Good Clinical Practice
  • Schedule Y – Drugs and Cosmetics Rules, India
  • CDSCO BA/BE Study 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: Daily Safety Monitoring Log Template

Subject ID Date Time BP (mmHg) HR (bpm) Temp (°C) Remarks
SUB001 17/04/2025 09:00 118/76 78 36.7 Stable

Annexure-2: Investigator Daily Review Sheet

Date Subject ID Findings Action Taken Reviewed By
17/04/2025 SUB001 Normal None Dr. Meena Joshi

Annexure-3: QA Safety Log Review Report

Date of Review Reviewed By Issues Noted CAPA Required Remarks
18/04/2025 Sunita Reddy Missed 3pm entry Yes Training needed

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial SOP release New SOP QA Head
17/04/2025 2.0 Expanded monitoring intervals and QA oversight Audit preparedness QA Head
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