What is a Clinical Protocol Document

What is a Clinical Protocol Document?

A Clinical trial is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.

Sample Protocol Template is given below:

Protocol Signature Page

Protocol Signature Page – Participating Sites

Abstract

List of Abbreviations

Table of Contents

1 Introduction

    1.1 Background on Indication

    1.2 Background on the Investigational Product(s) and Associated Known Toxicities

    1.3 Rationale for the Proposed Study

    1.4 Rationale for the Dose Selection/Regimen

    1.5 Correlative Studies

2 Study Objectives

    2.1 Hypothesis

    2.2 Primary Objective and Endpoint(s)

    2.3 Secondary Objective(s) and Endpoint(s)

    2.4 Exploratory (Correlative) Objectives

3 Study Design

    3.1 Characteristics

    3.2 Sample Size

    3.3 Eligibility Criteria

        3.3.1 Inclusion Criteria

        3.3.2 Exclusion Criteria

    3.4 Inclusion and Recruitment of Women and Minorities

        3.4.1 Eligibility of Women and Minorities

        3.4.2 Recruitment of Minority Groups

    3.5 Inclusion Across the Lifespan

    3.5.1 Age Range of Participants

    3.5.2 Study Design/Recruitment Considerations Related to Age Groups

    3.6 Duration of Treatment

    3.7 Duration of Follow Up

    3.8 Randomization Procedures

    3.9 Primary Completion

    3.10 Study Completion

4 Investigational Products

    4.1 Description, Supply and Storage of Investigational Products

        4.1.1 <<Investigational Product #1>>

        4.1.2 <<Investigational Product #2>>

    4.2 Accountability Records for Investigational Product(s)

    4.3 Ordering Investigational Product(s)

5 Treatment Plan

    5.1 Dosage and Administration

        5.1.1 Other Investigational Procedures/Modalities

    5.2 Dose Escalation Schedule

    5.3 Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

        5.3.1 Dose Limiting Toxicity

        5.3.2 Maximum Tolerated Dose

    5.4 Dose Modifications and Dosing Delays

    5.5 Stopping Rules

6 Study Procedures and Schedule of Events

    6.1 Study Calendar

    6.2 Participant Registration

    6.3 Schedule of Procedures and Assessments

        6.3.1 Screening Period

        6.3.2 Treatment Period

        6.3.3 Safety Follow-up

        6.3.4 Long Term/Survival Follow-up

    6.4 Correlative Studies

    6.5 Use of Concomitant Medications

    6.6 Dietary Restrictions

    6.7 Prohibited Medications

7 Reporting and Documentation of Results

    7.1 Evaluation of Efficacy: Antitumor Effect – Solid Tumors

        7.1.1 Definitions

        7.1.2 Disease Parameters

        7.1.3 Methods for Evaluation of Measurable Disease

        7.1.4 Response Criteria

    7.2 Evaluation of Efficacy: Antitumor Effect – Hematologic Tumors

    7.3 Evaluation of Safety

8 Safety Parameters

    8.1 Definitions

        8.1.1 Adverse Event (AE)

        8.1.2 Serious Adverse Event (SAE)

        8.1.3 Unanticipated Problem (UP)

    8.2 Classification of Adverse Events

        8.2.1 Severity

        8.2.2 Attribution

        8.2.3 Expectedness

    8.3 Recording of Adverse Events

    8.4 Expedited Reporting

        8.4.1 Reporting to the HDFCCC Data and Safety Monitoring Committee

        8.4.2 Reporting to Institutional Review Board

        8.4.3 Expedited Reporting to the FDA

        8.4.4 Reporting to Industry Partners/External Collaborators

    8.5 Follow-up of Adverse Events

    8.6 Adverse Events Monitoring

9 Statistical Considerations and Evaluation of Results

    9.1 Sample Size Considerations

        9.1.1 Sample Size and Power Estimate

        9.1.2 Randomization

        9.1.3    Stratification Factors

        9.1.4 Accrual Estimates

    9.2 Interim Analyses and Stopping Rules

    9.3 Analyses Plans

        9.3.1 Population(s) for Analysis

        9.3.2 Primary Analysis (or Analysis of Primary Endpoints)

        9.3.3 Secondary Analysis (or Analysis of Secondary Endpoints)

        9.3.4 Exploratory/Correlative Analysis/Assessments

10 Study Management

    10.1 Pre-study Documentation

    10.2 Institutional Review Board Approval

    10.3 Informed Consent

    10.4 Changes in the Protocol

    10.5 Handling and Documentation of Clinical Supplies

    10.6 Case Report Forms (CRFs)

    10.7 Oversight and Monitoring Plan

    10.8 Record Keeping and Record Retention

    10.9 Publications

    10.10 Multicenter communication (for multicenter studies only – remove this section if the study will only be conducted at UCSF)

    10.11 Regulatory Documentation (for multicenter studies only – remove this section if the study will only be conducted at UCSF)

11 Protection of Human Subjects (for multicenter studies only – remove this section if the study will only be conducted at UCSF)

    11.1 Protection from Unnecessary Harm

    11.2 Protection of Privacy

12 References

Appendix 1 Performance Status Criteria

Appendix 2 Data and Safety Monitoring Plan

Appendix 3 Prohibited Medications List

Next: Statistical Analysis Plan