Protocol Structures

Section

Clinical Trial Research Protocol Content

Non-Clinical Trial Research Protocol Content

A. Introduction

Literature review, disease/intervention background, investigational product or intervention rationale, and prior evidence.

Literature review, study background, problem statement, local relevance, and rationale.

B. Objectives

Primary and secondary objectives, including safety, efficacy, pharmacological, or intervention-related objectives.

General and specific objectives aligned to the research question and study design.

C. Justification

Need for the drug, device, vaccine, procedure, or intervention; expected benefits and future clinical/public health implications.

Importance of the study, knowledge gap, relevance to health systems, communities, policy, or practice, and expected implications.

D. Methodology

Trial design, phase, randomization/blinding where applicable, intervention, comparator, setting, duration, eligibility, sample size, recruitment, follow-up, outcomes, safety monitoring, and analysis plan.

Study design, setting, duration, population, eligibility, sampling method, sample size where applicable, recruitment, data collection methods, study tools, variables/themes, and analysis plan.

E. Ethical Considerations

Risk-benefit assessment, informed consent, vulnerable populations, privacy, compensation/reimbursement, trial-related injury, safety reporting, adverse events, withdrawal, and stopping rules

Risk-benefit assessment, consent or consent waiver where applicable, vulnerable populations, privacy, confidentiality, data protection, voluntary participation, minimization of harm, and withdrawal where applicable.

F. Informed Consent Documents

Translated consent forms, assent/parental consent where applicable, genetic study consent where applicable, version number, date, and page numbering

Consent forms where applicable, translated forms where applicable, assent/parental consent where applicable, consent waiver justification for minimal-risk or records-based studies, version number, date, and page numbering.

G. Data Collection Tools

Case report forms, laboratory forms, safety reporting tools, trial visit schedules, and trial-specific instruments.

Questionnaires, interview guides, focus group guides, data abstraction forms, observation checklists, and records review tools.

H. Data Management and Analysis

Data capture, source verification, DSMB plan, statistical analysis plan, confidentiality, storage, access control, and data sharing.

Data handling, anonymization/pseudonymization, storage, access control, confidentiality, qualitative or quantitative analysis, data sharing, and archiving.

I. Regulatory / Administrative Requirements

PPB approval where applicable, NACOSTI licence, trial registration, insurance/indemnity, GCP certificates, CVs, and sponsor documents.

NACOSTI licence where applicable, institutional/site approvals, CVs, data sharing agreements, community/site permissions, and relevant administrative documents.