Version No: 1.0 / Clinical Research Centre / Page 3 of 3
Date: <dd/mm/yyyy> / Study Closeout Report / TP-G-4-01-01

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May not be used, divulged, published or otherwise disclosed without the consent of

The Director, Clinical Research Centre

STUDY CLOSEOUT REPORT

Study Title / Insert title / Protocol Number / Insert number
Study Site / Insert site / NMRR I.D. Number / Insert number
Principal Investigator (PI) / Insert name> / PI’s Contact Number / Insert contact

Recruitment details:

Date recruitment started / dd/mm/yyyy
Date of last patient being recruited / dd/mm/yyyy
Number of patients approached / Insert number
Number of enrolled participants / Insert number
Number of withdrawn participants / Insert number
Number of participants completed study / Insert number
Number of participants lost to follow-up / Insert number
Reasons for patient lost to follow-up / Insert reason

Site closure activities:

(Please tick (√) and comments as appropriate)

Monitoring activities / Yes / No / Comment
Were there any violations of the protocol? / Insert comment
Were there any deviations from the eligibility criteria? / Insert comment
Was the participant recruitment log completed? / Insert comment
Have any patients been unblinded? / Insert comment
Has unblinding been documented? / Insert comment
Is there any important documentation remaining that should be returned or destroyed? / Insert comment
Informed Consent / Yes / No / Comment
Have all participants signed the consent form before study-related assessments were made? / Insert comment
Were any consent forms unsigned or unavailable? / Insert comment
CRF review / Yes / No / Comment
Is there a completed CRF for each participant? / Insert comment
Do any data clarifications or queries need to be resolved? / Insert comment
Adverse events / Yes / No / Comment
Do any of the previously reported SAEs need follow-up? / Insert comment
Since the last reporting period, new SAEs have occurred? (If yes, fill the table below) / Insert comment
SAE / Start date / Stop date / Relationship to intervention / Expected or Unexpected / Outcome
<Insert type of SAE> / <dd/mm/yyyy> / <dd/mm/yyyy> / <Insert relationship> / < Insert Expected or Unexpected> / <Insert outcome>
Pharmaceutical or Device Interventions / Yes / No / Comment
Was the final pharmaceutical or device inventory checked? / Insert comment
Were there any problems with pharmaceutical or device inventory? / Insert comment
Has any of the pharmaceuticals or devices been returned or disposed? / Insert comment
Are all pharmaceuticals or devices accounted for? / Insert comment

Site closure activities:

(Please tick (√) and comments as appropriate)

Regulatory documentation / Yes / No / Comment
Are there any changes regarding financial disclosures or conflicts of interest that need to be noted? / Insert comment
Do any documents require follow-up or revision according to regulatory requirements? / Insert comment
Ethics Committees / Yes / No / Comment
Have any SAE/ violations/ deviations been submitted? / Insert comment
Has the final ethics report been submitted? / Insert comment
Does the coordinating site have a copy of the letter from MREC acknowledging site closure? / Insert comment
Site discussions with coordinating centre– have the following been addressed to your satisfaction?
(If applicable) / Yes / No / Comment
Accomplishments of the study site. / Insert comment
Remaining problems or issues and corrective actions. / Insert comment
Obligations concerning records retention. / Insert comment
Final payment policy. / Insert comment
Publication policy. / Insert comment
Progress of participants requiring additional follow-up. / Insert comment
The inclusion of an explanatory comment for all unresolved entry violations. / Insert comment
The resolution of remaining data clarification issues. / Insert comment
What to expect in the event of a regulatory inspection. / Insert comment
To notify coordinating site ASAP if an inspection by a regulatory agency is pending. / Insert comment

Action items: <Insert actions>

Other comments: <Insert comments>

Form completed by:

Signature: <Sign here
Name: <Name
Date: <dd/mm/yyyy