Ghana Police Hospital
Prime Healthcare Excellence
info@ghanapolicehospital.com
24-hour service
0531056473
IMPORTANT NOTICE: No amendment to an approved research study may be implemented without prior written approval from the Ghana Police Hospital Institutional Review Board (IRB), except where necessary to eliminate immediate hazards to participants. Submission of this form does not constitute approval of the proposed amendment.
Name of Person Submitting Form
Email Address
IRB Reference Number
(As assigned in the original approval letter)
Original Date of IRB Approval
Current Approval Expiry Date
Study Title
Principal Investigator (PI)
Institution / Affiliation
Telephone
Email
Type of Amendment Requested
(Select all that apply)
Protocol AmendmentConsent Document AmendmentInvestigator / Research Team ChangeData Collection Tool AmendmentStudy Site Amendment
Other (specify):
2.1 Summary of Proposed Change(s)
Provide a concise description of the proposed amendment(s).
2.2 Rationale for the Amendment
Explain why the amendment is necessary.
3.1 Protocol-Related Changes
ObjectivesStudy designSample sizeInclusion/Exclusion criteriaStudy proceduresStudy duration
Description of Protocol Changes
3.2 Informed Consent Changes
Participant Information SheetInformed Consent FormLanguage(s) of consentConsent process or timing
Attach revised documents with tracked changes in Section 6.
3.3 Investigator / Research Team Changes
Addition of investigator(s)Removal of investigator(s)Change in roles or responsibilities
New Personnel Details
3.4 Study Site or Data Collection Changes
Addition of study site(s)Removal of study site(s)Change in data collection methods or tools
Site / Data Change Details
```html
4.1 Does the proposed amendment alter the risk profile of the study?
NoYes
If Yes, explain:
4.2 Does the amendment introduce any new risks to participants?
If Yes, describe the risks and mitigation measures:
4.3 Does the amendment affect participant consent?
NoYes (re-consent required / revised consent documents attached)
5.1 Has the amendment already been implemented?
Maximum file size: 5 MB per document and 2 MB for signature.
Revised Protocol
Revised Participant Information Sheet
Revised Informed Consent Form(s)
Revised Data Collection Tools
CVs of New Investigators
Other Supporting Documents
Specify document type:
Principal Investigator Declaration:
I confirm that the information provided in this Amendment Application Form is accurate and complete. I understand that the proposed amendment may not be implemented until written approval is granted by the Ghana Police Hospital Institutional Review Board (IRB).
Name of Principal Investigator
Signature
Date
Δ
