Case Report Form In Clinical Trial

socra.org

What Is Case Report Form 

Case Report Form is a specialized tool in clinical research for collecting all data from each participating subject or patient in a clinical trial. The sponsor usually develops or outsources CRF development to collect the specific data they need to test their hypotheses. The development of clinical trials represents a prominent part of the clinical trial. It also may affect the study process. Case Report Form is an essential tool for clinical research development.

Definition

As per the International Conference of Harmonization Guideline for Good Clinical Practices (ICH-GCP) is defined as “CRF is a printed optical or electronic document designed to record all the protocol- required information to be reported to the sponsor on each trial subject.”

learning.eupati.eu

What Is Types Of CRF?

There are two types of CRF

1. Traditional Paper CRF
2. Improvised Electronic CRF (eCRF)

Traditional Paper CRF:

Paper CRF is the traditional way, if the studies are small or vary in design paper CRF can be used.

Improvised Electronic CRF:

If studies are large with similar design eCRF are prepared. In the current global scenario, eCRF is preferred over paper CRF as they take less time and encourage the sponsor to carry out large multicentric studies at the same time. eCRF is designed in such a manner that data entry can be done with less error. The regulatory authorities are readily accepting submissions in which validated electronic data capture (EDC) systems are being used.

Elements Of A CRF:

A Case report form contains three main parts:

A Header:

The header contains key identifying information such as a study number, a site number, and participants id number.

Safety Module:

Safety Modules contains key safety analysis requirements which are found in the protocol. It includes demographic information, adverse events, medical history, physical exams, deaths, drop-outs, concomitant medication, patient disposition and eligibility confirmation.

Efficacy Module:

These modules are also referred to as standard CRF templates. It should be designed in a way that can be customized as per protocol requirements. These templated helps in conducting multiple studies in the same therapeutic area. The effectiveness of the protocol outlines the component required in the modules. The components of this module include the main test effectiveness endpoints, additional tests to measure effectiveness how lesions will be measured and the necessary diagnosis.

Who Should Design CRF?

CRF Designer: Member of the DM or CRF designer initiates the draft CRF preparation.

Review & Approval Team: Comprises of the lead DM, statistician, DB Designer, clinical monitor and sponsor/client.

Data Manager: Perform UAT and prepare CRF completion guidelines for investigator site.

Design & Review Team:

Design Team: Check the content of the CRF and ensure that the given information is clear and unambiguous.

CSM/CRA: Case Report Form is agreeable to the principal investigator for ensuring the reflection of core data requirements of the protocol.

Data Manager: Data Manager ensures the suitability of CRFs for the collection of data and for entry into clinical databases.

Clinician: Gives input on protocol requirements.

Statistician: Gives input to ensure CRF collects the required analysis parameters.

Frequently Asked Question

Question: What is the main purpose of the case report form?
Answer- Case report form is a printed optical or electronic document used in clinical trial research for collecting the data of each participating patient or subject in a clinical trial.

Question- What is the content found in the case report form?
Answer- 1) Inclusion or exclusion criteria

2) Demographics ( Patients information in an anonymised way)

3) The patients’ medical history

4) A description of the disease that patients are currently suffering or they are taking medicine.

5) Efficacy and safety parameters.

6) Which medicine, they are taking.

7) Termination of trail

Conclusion: The case report module contains the data obtained during the patients/subject participation during the clinical trial. This data is made anonymous by removing the patient’s name, medical record number, etc before sending them to the sponsor and it provides the patients with unique id numbers.

Disclaimer: All the content of this article is for information purposes only.

References: www.pubmed.ncbi.nlm.nih.gov

www.novatech-cro.com