What is a clinical trial protocol?


This post is part of 'Domain | General' series

A clinical trial protocol is a detailed plan that outlines the objectives, design, and conduct of a clinical trial. The protocol is developed by the sponsor of the trial (typically a pharmaceutical company or medical device manufacturer) and is reviewed and approved by regulatory agencies, such as the US Food and Drug Administration (FDA), before the trial can begin.

The clinical trial protocol includes a range of information, including:

  • The purpose of the trial and the research question it is trying to answer
  • The inclusion and exclusion criteria for the trial, which define the characteristics of the study population
  • The number and location of the study sites and the number of participants
  • The treatment regimen (including dosage and administration)
  • The schedule of visits and procedures for the participants
  • The criteria for evaluating the effectiveness and safety of the treatment
  • The plan for collecting and analyzing the data
  • The provisions for monitoring the trial and ensuring the safety of the participants

The clinical trial protocol is a key document that guides the conduct of the trial and ensures that it is conducted ethically and in accordance with the relevant regulations. It is an important tool for coordinating the various activities and stakeholders involved in the trial, and helps to ensure that the trial is conducted in a consistent and reliable manner.





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General
What is MedDRA
What is WHO-DD
What is ATC classification of Drugs
Tables vs Listings in Clinical Trial Analysis
Analysis Sets in Clinical Trial Data Analysis
Validation of TFLs in Clinical Trials
Vital Signs in Clinical Trials
ECG in clinical trials
Solid tumors vs other cancers
What is 21 CFR Part 11?
Declaration of Helsinki
Importance of Harmonization (ICH)
The Drug development process
Overview of clinical trial process
What is a clinical trial?
What is Pinnacle 21?
Who conducts clinical trials?
Why are clinical trials conducted?
What are the phases of clinical trials?
Why are oncology clinical trials considered critical?
What is a clinical trial protocol?
Case Report Form (CRF)
Database annotated CRF
What is a clinical trial registry?
Factors affecting drug metabolism and activity
Prior and Concomitant medications
Inclusion/Exclusion Criteria in a clinical trial
What happens after a clinical trial is completed?
The Investigational New Drug Process
Preclinical Research
Drug discovery
FDA Drug Review
What is the importance of baseline characteristics in a clinical trial?
Why do we need CDISC standards?
What is a clinical development plan?
What is a clinical study report?
"Exploratory study" vs "Confirmatory study"
What is ICH?
Clinical trial registries
Efficacy data vs Safety data
What is clinical data management?
Clinical SAS Programmer
Statistical Analysis Plan
The 27 System Ogran classes (MedDRA)
What is RECIST 1.1?

Trial design aspects
What is a crossover clinical trial?
What is blinding in clinical trials?
What is an open-label clinical trial?
What is randomization in clinical trials?

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What is a cohort?

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What is a computer?
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What is SAS?
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What does a SAS program contain?

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Introduction to SAS interface
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Rules for character SAS informat names

Proc freq
Count the number of times a particular value occurred in a variable of a dataset

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Check the list of variables in a SAS dataset

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Delete all sas datasets from a library
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How to derive baseline flag in SDTM
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How to derive study day variable in SDTM
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What is SDTM annotated Case Report Form (acrf.pdf)
How to convert original results to standard results using conversion factors

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What information does SDTM.DM (Demographics) contain?

Adverse Events
What is causality assessment?
What information does SDTM.AE (Adverse Events) contain?

Disposition
What information does SDTM.DS (Disposition) contain?

Concomitant Medications
What information does SDTM.CM (Concomitant/Prior Medications) contain?

Procedures
What information does SDTM.PR (Procedures) contain?

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What is ADaM?

ADSL
What is ADSL as per ADaM standard?

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What is BDS as per ADaM standard?

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What is correlation?
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ANCOVA - Basic example
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ttest - introduction
Multiple imputation
What is Standard error
What is Fishers exact test
What is Least Squares Means

General

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