Checklist For Clinical Trial Protocols Involving Human Subjects And Generating Data Intended To Be Submitted To Regulatory Authorities
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2CHECKLIST FOR CLINICAL TRIAL PROTOCOLS INVOLVING HUMAN
SUBJECTS AND GENERATING DATA INTENDED TO BE SUBMITTED TO
REGULATORY AUTHORITIES
(Source: ICH Harmonized Tripartite Guideline for Good Clinical Practice 1996)
Tick (√)
Comments
if
submitted
GENERAL INFORMATION
Protocol identifying number and date
Name and address of sponsor
Name and institution of investigator/s
BACKGROUND
Name and description of investigational product.
Summary of findings from nonclinical and clinical
studies.
Description and justification for route of
administration, dosage, and treatment periods.
Statement that trial will be conducted in compliance
with GCP and other regulator requirements.
Description of study population.
Literature review.
OBJECTIVES AND PURPOSE
Detailed description of objectives and purpose.
TRIAL DESIGN
Statement of primary and secondary endpoints to be
measured.
Description of type / design of trial.
Measures taken to minimize bias – randomization,
blinding.
Trial treatment(s) and dosage, dosage form,
packaging, labeling.
Expected duration of subject participation.
Sequence and duration of all trial periods including
follow-up, if any.
Stopping rules / discontinuation criteria for subjects,
parts of trial and entire trial.
Accountability procedure for study products.
Maintenance of randomization codes and procedures
for breaking codes.
Identification of data to be directly recorded on CRF.
SELECTION AND WITHDRAWAL OF
SUBJECTS
Inclusion criteria.
Exclusion criteria.
Subject withdrawal criteria.
When and how to withdraw subjects from trial.
Type and timing of data to be collected from
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