Introduction Importance of CRF CRF relationship to protocol Elements of CRF Type of CRFs

CRF Development Process

Definition The CRF is the tool that is used to collect pre-defined data from subject in a clinical trials. The ICH guidelines for Good Clinical Practice define the CRF as: 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 essentials of the Case Report Form are: Records Clinical Trial Data Collects relevant data Efficient, accurate and complete data processing Data Analysis, Consistent Reporting Subject Tracking Facilitates exchange of data Support of labeling claims Used for Promotional Materials and NDAs

Below are the insights which relates the CRF and the protocol: The data required by the protocol are reported accurately on the CRFs.

Adverse events, concomitant medications and intercurrent illnesses are

reported in accordance with the protocol on the CRFs.

Visit procedures are recorded in accordance with the protocol on the CRFs.
All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs as per the protocol.

The elements of the case report form consist of below major parts: Header Footer Safety modules Efficacy modules

Header:

Footer:

Safety Module

Efficacy Module

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

There are two types of CRFs:

Paper CRF Electronic CRF- for remote data capture and entry (RDC and RDE).

Statistician Medical writer Database Designer/Programmer Clinical Monitor Investigator/Site Coordinator Data Entry Personnel

Before initiating the designing of the case report forms the below criteria's should be considered, whether a

CRF should be designed during protocol development Or CRF should be designed after protocol finalization.
The notes below provides the pros and cons of the two criteria's and the general tips for CRF writing.

The CRFs should be designed to capture enough data to fully evaluate the research questions asked in the protocol and collect adverse event data for safety reports and processes. When designing CRFs, the content and structure of the data items (or questions) to be included in the CRF should be considered first rather than the modality or appearance of the CRF. The flow of study procedures and typical organization of data in a source data should be taken into account as well Design the CRF with the primary safety and efficacy endpoints in mind as the main goal of data collection and pretest and review them prior to finalization and approval.

The CRF development process is discussed using a four stage model:

Predevelopment Content Designing Style Design Review

Predevelopment The predevelopment phase is a short period that occurs after the study protocol has been established and agreed upon by all study investigators. The main objective of this phase is to becoming familiar with all parts of the study protocol.

Content Designing The design of the CRF is crucial to the success of your clinical trial. For this reason,

design standards in content and style can be applied to ensure the proper
organization and visual appeal of the forms.

A meticulous and careful design strategy will generate better comprehension and
easier completion of CRFs for clinicians, which results in fewer questions and queries in later stages of the trial.

Style Design The style and layout of the CRF is just as important as the content it contains. Each subject involved in the study will have many CRFs; therefore, the proper labeling and organization of the forms is critical. Each CRF should be standardized through the header and footer. The header should include the study/protocol number, the site number, subject number and initials, fill-in-date. The footer should include the date of printing and the revision number, page number, Investigator signature (if necessary on all pages). To use one set of CRFs for each patient at each center, there are usually blank boxes for center number, patient number, patient initials, and date.

Review The CRF review includes the following team of members who review and provide necessary comments or inputs. Lead Statistician Lead Medical Writer Lead Programmer Lead Data Manager Lead CRA Investigator Others