BASICS OF CASE REPORT FORM DESIGNING IN CLINICAL RESEARCH

Designing a CRF is an art that should be based on scientific practices & the design should be implemented keeping the end-user in mind.

Case report forms contain data obtained during the patient’s participation in the clinical trial.

The primary objective of CRF designing is to gather complete & accurate data by avoiding duplication & facilitating the transcription of data from source documents onto the CRF. CRF should be designed with the primary safety and efficacy endpoints as the main goal of data collection.  

Data should be organized in a format that facilitates & simplifies data analysis.

Collection of large data will result in wasted resources in collecting & processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry.

 CRF DESIGN PRINCIPLES:

 

When designing a case report form, general principles to consider include:

•           Components are organized chronologically, clearly identifying the visit or data collection point.

•           Designated area for sign-off, at eligibility review, and the end of the CRF.

•           Fields are organized to enter data into the case report form in a logical order eg: following the order of study procedures during a trial session.

•           The header on every page provides relevant identifying information  eg: trial name, protocol number, patient trial number.

•           Indications are included as to which case report form pages are applicable to particular visits .

•           The case report form is version controlled ,with version number & date at a minimum.

 

CASE REPORT FORM CONNECTIVITY /WELL REFERENCED CRF:

•           Linking of CRF ( paper CRF & e CRF ) pages wherever necessary is known as CRF connectivity . Each CRF booklet is assigned with unique subject ID  and it is the duty of site personnel to make sure that same ID is entered on all pages of CRF booklet.

•           Consistently entered subject ID will help in tracking the missing CRF pages. The fields such as protocol ID, site code, subject ID, patient initials make database designing easier and helps linking CRF pages to the study database.

•           The CRF version number is critical field that prevents an incorrect CRF page being used.

 

CHALLENGES:

•           Commonly encountered challenges in CRF designing are consistency in  the design, collection, of precise data and user – friendliness.

 

•           These challenges can be overcome by overcome by proper planning by a team of data management personnel, biostatisticians, clinicians, and medical writers.

 

•           Objective should be defined clearly before designing. Consistent design is a crucial aspect as it reduces the number of mistakes in data entry. It is a great advantage when using them across various studies.

 

COMPLETION GUIDELINES:

A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF & protocol.

CRF completion guideline as it is study specific. It should be prepared in a such way that it enables the site personnel to complete the CRF with ease & legibility.

CONCLUSION:

Case report form design is the initial step in translating the protocol into the standard questionnaire and is paramount to a successful clinical trial.

Standard CRF should be designed in such a way that it helps the collection of consistent and valid data, ultimately resulting in the submission of data to regulatory authorities and its acceptance.

 

REFERENCES

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/

https://www.egnyte.com/guides/life-sciences/case-report-formv

https://pubmed.ncbi.nlm.nssih.gov/25276625/

Name: P. Rithika Rashmi

Qualification: Pharm. D

Student ID: CLS_220/112023