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Edit Template

    SECTION 1: STUDY IDENTIFICATION

    IRB Reference Number

    Title of Study

    Principal Investigator

    Institution / Affiliation

    Original Date of Ethical Approval

    Current Approval Expiry Date

    SECTION 2: TYPE OF SUBMISSION

    Select Submission Type

    [radio* submission-type use_label_element "Continuing Review / Renewal" "Study Closure (Completed as Approved)" "Early Termination (Stopped before Completion)"]

    SECTION 3: PROGRESS REPORT (FOR CONTINUING REVIEW)

    3.1 Summary of Study Progress to Date

    3.2 Number of Participants Approved vs Enrolled

    3.3 Summary of Any Deviations from Approved Protocol

    3.4 Summary of Adverse Events or Unanticipated Problems

    3.5 Assessment of Ongoing Risk-Benefit Balance

    SECTION 4: AMENDMENTS AND CHANGES

    Have there been any amendments?

    Attach Amendment Details (if applicable)

    SECTION 5: REQUEST FOR CONTINUED APPROVAL

    Requested Continuation Period

    SECTION 6: STUDY CLOSURE / TERMINATION REPORT

    6.1 Date of Study Completion or Termination

    6.2 Reason for Early Termination (If Applicable)

    6.3 Confirmation that no further participant contact or data collection will occur

    [radio* participant-contact-confirmation use_label_element "Yes" "No"]

    6.4 Summary of Final Outcomes

    SECTION 7: DATA MANAGEMENT AND FINAL DISPOSITION

    Describe plans for final data storage, confidentiality, and dissemination of results

    SECTION 8: DECLARATION AND SIGNATURE


    I certify that the information provided in this report is accurate and complete. I confirm that the study has been conducted in accordance with the approved protocol and ethical requirements and that the IRB has been notified of study completion or termination where applicable.

    Name of Principal Investigator

    Signature

    Date