MCA-F-501/10, version 2 – 24 January 2025 — Clinical Trial/Study Summary Report
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Contents
MEDICINES CONTROL AGENCY
MCA
THE GAMBIA
CLINICAL TRIAL/STUDY
MCA-F-501/10
SUMMARY REPORT
MEDICINES CONTROL AGENCY
Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia
Website: www.mca.gm; E-mail: info@mca.gm; Tel. No.: +2204380632
SECTION A ADMINISTRATIVE INFORMATION
Title of Clinical Trial/Study:
Sponsor: (Please insert name and address),
Principal Investigator: (Please insert name, address, email, phone)
Protocol Number MCA CT Number
PACTR Number Other numbers
Date of Start of the Trial/Study:
Date of End of the Trial/Stusy:
Date of interim data analysis,
if any:
Date of final data analysis:
Was it an early termination ☐ Yes ☐ No
Date of this report:
SECTION B General Information about the Clinical Trial/Study
Main objectives of the trial/study:
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Clinical Trial Summary Report MCA The Gambia
Trial/study design:
Scientific background and explanation of rationale:
Measures of protection of participants taken:
Background therapy:
Statistical methods used:
SECTION C POPULATION OF PARTICIPANTS IN THE GAMBIA
Inclusion criteria
Exclusion criteria
Number of participants screened
Number of participants recruited
Number of participants included in the
clinical trial/study
Number of participants withdrawn
SECTION D INVESTIGATIONAL PRODUCTS
Description of investigational products used:
Randomisation details:
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Clinical Trial Summary Report MCA The Gambia
Blinding details (if applicable):
Accountability (repeat information for each product):
Total quantity imported
Total quantity purchased locally
Total quantity used in the trial
Total quantity wasted (spilled/lost)
Total quantity onsite (if applicable)
Total quantity returned to sponsor (if
applicable)
Total quantity disposed (if applicable)
SECTION E BASELINE CHARACTERISTICS
Age and age group breakdown
Gender and gender breakdown
Trial/Study Specific Characteristic
(if applicable)
SECTION F END POINTS
End point definitions*:
End Point #1 Statistical Analyses:
End Point #2 Statistical Analyses:
*Information shall be provided for as many end points as defined in the protocol
SECTION G ADVERSE EVENTS
Description of overall adverse event experience:
Summary and narratives of serious adverse events, indicating those suspected
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Clinical Trial Summary Report MCA The Gambia
SECTION G ADVERSE EVENTS
to be related to the IMP (attach tables)
Summary of non-serious adverse events (attach tables)
SECTION H ADDITIONAL INFORMATION
Substantial Modifications:
Interruptions and re-starts
Limitations:
Sources of potential bias and imprecisions:
For clinical trials/studies replicating trials/studies on already authorised inves-
tigational products and used in accordance with the terms of the marketing au-
thorisation
Indicate identified concerns to relevant aspects of the efficacy of the IP
SECTION I OVERALL RESULTS OF THE CLINICAL TRIAL/STUDY
List the documents attached to this report
I, the undersigned certify that this clinical trial was conducted in compliance with
ICH-GCP Guideline including the archiving of essential documents, and any ap-
plicable regulatory requirements, and that the information submitted in this re-
port is accurate and complete.
Signature of Principal Investigator in The Gambia:
Signature Date
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