Protocol Checklist - Basic and Additional Elements
[Protocol version and date]
[Protocol number]
Appendix 3.4.2: Protocol Checklist - Basic and Additional Elements
Please review the following checklist and confirm that each required element is addressed within your Protocol. Check each box as directed, if a section is not applicable, please indicate by using ‘N/A’ in the box provide. If you have any questions regarding the completion or content of this form, please contact your Activity Manger for further assistance. Once the checklist has been completed, the Principal Investigator should sign and date the form confirming their review of the submitted materials.
PrincipalInvestigator:
Name
Title
Address
Email address
Organization: Ministry of Health HIV/AIDS Unit
Protocol Title: Biological and Behavioural Surveillance Survey among Men who have sex with Men in [country]
Protocol Number:
Protocol Version and Date: Version 1. [date]
Please check each box to indicate that each component is addressed with your protocol. Kindly note that not all of the following requirements may be applicable to your study. If not applicable, please indicate by using ‘N/A’ where appropriate.
Editorial AssurancesX / Version number and version date provided on Protocol coverpage.
X / Page numbers provided on each page
X / Cooperative Agreement number provided in Protocol header
X / Principal Investigator’s name provided in Protocol footer
Protocol Content Assurances
Project overview
X / Title
X / Protocol summary
X / Listing of all investigators
Introduction
X / Literature review/ current state of knowledge about project topic
X / Justification for study
X / Study design/ location (s)
X / Objectives
X / Hypothesis or questions to be investigated
X / General approach
Procedures/ Methods
Design
How study design or surveillance system addresses hypothesis and meets objectives / X
Audience and stakeholder participation / X
Cost benefit/ prevention effectiveness / X
Study time line / X
Study Population(s)
Description and source of study population and catchment area / X
Case definitions / N/A
Participant inclusion criteria / X
Participant exclusion criteria / X
Justification of exclusion of any sub-segment of the population / N/A
Estimated number of participants / X
Sampling, including sample size and statistical power calculations / X
Enrollment procedures / X
Consent procedures (to include reading scale determination) / X
Variables/ Interventions
Variable descriptions / N/A
Study instruments, including questionnaires, laboratory instruments and analytical tests / X
Intervention or treatment details as applicable / X
Study outcomes and relevance / X
Description of training for all study personnel / X
Data Handling and Analysis
Data analysis plan, tables and figures, including statistical methodology / X
Data collection methods / X
Information management and analysis software / X
Data entry, editing and management, including handling of data collection forms, different versions of data / X
Data storage and disposition / X
Quality Control/ Quality Assurance measures / X
Handling results in the absence of a reference test – including how specificity and sensitivity are affected / X
Measurement/ estimation and adjustment for cross reactivity and how they will be accounted/ adjusted for in the analysis / X
Validation procedures for tests used to confirm results of new testingmethodologies / N/A
Bias in data collection, measurement and analysis / X
Description of intermediate reviews and analyses / X
Limitations of study / X
Handling of Unexpected or Adverse Events
Response to new or unexpected findings and to changes in the study environment / X
Identifying, managing and reporting adverse events / X
Anticipated products or interventions resulting from the study and their use / X
Dissemination of results to the public, SAG, and others. / X
Study Budget
References - N/A
Appendix Material
Data collection forms / X
Proposed tables and figures
Other relevant documents
Scientific Peer Review
Conflicts of Interest / X
Principal Investigator Review: Date:
THE FOLLOWING SECTION IS TO BE COMPLETED BY YOUR ACTIVITY MANAGER
Outcome:
Protocol has been reviewed and addresses ALLapplicable protocol components:
Yes No (If not, please provide specific reasons.)
Review Comments:
Activity Manager Review: ______Date: ______
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Source: CDC:DEVELOPING A PROTOCOL: A Guide for CDC Investigators