Protocol, ICF, and CRF Development

Hundreds of clinical trials are conducted on a daily basis all over the world. There may be successful clinical trials as well as unsuccessful trials. The success ratio can never be defined by 100 percent as the process is complicated yet risky. There are a number of norms and guidelines created by the officials to mainly assure the safety of the subject involved in the clinical trials. The norms can even ensure the investigators and physicians with better success rates. Few of the norms include the protocol development, Informed Consent for clinical trials (ICF) and Case Report Form (CRF). The following acts as powerful guidelines for the proper functioning of the clinical trial. The guidelines are made in keeping the safety of the investigators and subject in mind. The following are the important documents and steps to take at the time of initiation of the clinical trial. At certain events, the clinical trials are even stopped due to the lack of information given to the subject. Improper or inaccurate reports of the clinical trials may also even result in major wrong conclusions. To curb every possible error, the following tools must be followed up to ensure the proper and successful execution of the clinical trial.


Protocol Development

A protocol must be the initial step for every investigation related to the clinical trial. The protocol development is defined in The Medicines for Human Use (Clinical Trials) regulations in Part 1(2). The ideal protocol is based on compliance with the regulatory terms. It must be maintained thoroughly as it contains all the detailed information of the further process along with the schedules of the clinical trial. The schedules and processes mainly include rationale, the background of the subject participating in the clinical trial, schedules of tests, duration of the trial, medications of the clinical trial, statistical and design considerations and the objective of the trial (the purpose for which the clinical trial has been conducting).

The protocol is also responsible for keeping the records of the analyzed data from the trials with the safety measures for the participants. Every action undertaken at the time of the clinical trial should be in adherence to the protocol. There may be minor deviations from the protocol is not considered as a good practice as it may majorly affect the success rate of the clinical trial. It is even recommended to use simple and regular terms for the easy understanding of both subject and investigators. If any special terms are used in the development of the protocol, then they must be explained or clarified beforehand. The protocol is also not considered to be amended or changed in the middle or after the execution of the respective study. If in case, any protocol amendment is necessary, then it must be approved by the official ethics committee.


Informed Consent Form (ICF)

An informed Consent form is a necessary document regarding the safety of the subject participating in the clinical trial. Before the enrollment of the subject into the execution of the clinical trial, an ICF shall be given to the potential research participant/subject. It is highly necessary to inform the participant in clear and legible words in both oral and written senses. The process of ICF consists of the series of oral conversation and an official document regarding the clinical trial participation between the subject and principal investigator (PI) along with the health professionals. The subject should be fully informed about the future risks related to the clinical trial along with the duration and medications. The ICF may include the duration, purpose, risk, costs, additional expenses for carrying of the trial, description of procedures, volunteer rights and benefits of the trial. He or She is free to call back the given consent at any point of the trial without any further arguments, penalties or special reason. No decision regarding the clinical trial shall be forced upon the subject. The process of Informed Consent includes:

  • The PI has a discussion about the risk related to trial with the safety measures and various aspects of the trial with the potential subject.
  • The potential subject is given sufficient time to think and have a talk with the family members, relatives and loved ones. He/She is free to ask any questions regarding the trial.
  • If the potential subject agrees to get involved in the trial, then he or she gives the voluntary consent by dating and signing the written informed consent document. The potential subject will also receive a copy of the written consent.


Case Report Form (CRF)

A Case Report Form (CRF) is an optical, electronic or printed document which is specially designed to collect the data and information described in protocol for every trial subject. CRF can make a significant impact on the way of the collection of data. It is a good practice to keep the outline for the database ready before designing the CRF. The CRF made similar to the protocol, by the sponsor or by the person assigned by the sponsor. It is the reporting formula where the investigator can keep the record of the specifically collected data. The making of CRF doesn’t need any official approval by the authorities, but a few guidelines and requirements must be followed up for the appropriate design, handling and usage. The data collected should be 100 percent accurate and provide true information regarding every study subject. The CRF is used for various purposes including:

  • To ensure the fulfilling of regulatory authorities requirements for the collection of the data.
  • To ensure the collection of data in accordance with the study protocol
  • To facilitate the comprehensive, effective data analysis and processing and promote the safety data sharing between different departments of institution and study team.

The protocol development, ICF and CRF are the significant steps to undertake before the conduction of the clinical trial. All these measures are taken to improve the level of safety for the subjects participating in the trial as well as increase the responsibility of the respective investigators.

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