CRF Case Report Form - Design

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The CRF is the elementary tool designed based on the Clinical Trial protocol. Once a thorough understanding of the Trial protocol is achieved, the data to the captured from a Trial participant (subject) is identified. These data points or fields are then carefully placed in a set of forms termed as Case report Forms (CRF). As per ICH Guidelines CRF is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the Sponsor on each trial Subject.

The following data/factors must be captured in CRF:

1. Clinical Study identifiers - Study Code/ Name, Date, Trial phase etc. necessary for unique identification of the Study
2. Study subject identifiers - Subject Code, Randomisation No., Subject Initials (Never full name is collected), etc.
3. Subjects informed consent signature date and details pertaining to the informed consent.
4. Subject's Inclusion and exclusion criteria for enrollment into the clinical study.
5. Subject Demographics details - Age, sex, height, weight, ethnicity etc.
6. Subject personal Histories - Pregnancy, Smoking, Dietary, past/current illness and treatments etc.
7. Concomitant use of other medicines and non-medicinal interventions/therapies
8. Drug Administration details - Dose, dosage schedule, compliance record.
9. Duration of treatment.
10. Duration of observational period.
11. Recording of efficacy parameters listed in protocol with date and time.
12. Record of all Adverse Events (AE), type, duration, intensity and outcome/consequence of the AE.
13. Reasons for withdrawal from the study and breaking the randomisation code (if any).

In addition to these parameters - additional section like Subjects Dietary regimens, Quality of life Questionnaires (SF 36), Subject Diary may also be part of the CRF's.

Each of the above parameters is usually collected in individual pages of the CRF. CRFs are collection of many such individual pages, and are organised based on the number of times the subject has to show up (visits) to the research facility.

Traditionally for a study requiring multiple participant subject visits, the CRF pages of each subject is maintained in a CRF Binder (which resembles a big and heavy book). Each CRF Page in the binder has 2 to 3 copies apart from the original page. Special NCR (No carbon required) papers are used to print the copies of each CRF page. Each of the copies are printed in different colours (usually pink and yellow colours are used for copies; the original mostly is in White colour). There is though no regulatory requirement of separate colours for CRF page copies.

eCRF : These cart loads of Paper CRF bunches are completely avoidable if a Trial Sponsor opts for a Electronic Data Capture / Remote Data Entry, where the subject data is directly entered from the Remote Trial location (Site). The CRF pages instead being printed on paper in multiple copies, are designed in electronic format. Such electronic version of CRFs are termed as eCRFs.

Study Setup: eCRFs are created by programmers based on a Design document. The Design document contains information about the CRF Page, CRF Section, Field name and Field attributes. A sample is shown below: