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David W. Mailhot February 7, 2006

This document discusses the design of case report forms (CRFs) for clinical studies. It provides guidelines for CRF development, including collecting only required data, being clear and concise, and providing standardized response options. CRFs should collect safety and efficacy data specified in the study protocol. The development process involves drafting, reviewing by a team, and approving the CRF book before printing and distributing to research sites. Properly designed CRFs save time and money by being reusable, while poorly designed CRFs can impede data collection and analysis.

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71 views33 pages

David W. Mailhot February 7, 2006

This document discusses the design of case report forms (CRFs) for clinical studies. It provides guidelines for CRF development, including collecting only required data, being clear and concise, and providing standardized response options. CRFs should collect safety and efficacy data specified in the study protocol. The development process involves drafting, reviewing by a team, and approving the CRF book before printing and distributing to research sites. Properly designed CRFs save time and money by being reusable, while poorly designed CRFs can impede data collection and analysis.

Uploaded by

upendern
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Design of Case Report

Forms

David W. Mailhot
February 7, 2006
Case Report Form
 ..CRF
 Official clinical data-recording document or
tool used in a clinical study

PAPER RDC/RDE (Remote Data Capture,


Remote Data Entry)
Purpose
 Collects relevant data in a specific format
• in accordance with the protocol

• compliance with regulatory requirements

 Allows for efficient and complete data processing, analysis

and reporting
 Facilitates the exchange of data across projects and

organizations esp. through standardization


CRF Relationship to
Protocol
 Protocol determines what data should be collected
on the CRF
 All data must be collected on the CRF if specified

in the protocol
 Data that will not be analyzed should not appear on

the CRF
CRF Development
 Guidelines
 Collect data with all users in mind
 Collect data required by the regulatory

agencies
 Collect data outlined in the protocol

 Be clear and concise with your data questions

 Avoid duplication

 Request minimal free text responses


CRF Development
 Guidelines (con’t)
 Provide units to ensure comparable values
 Provide instructions to reduce misinterpretations

 Provide “choices” for each questions

• allows for computer summarization

 Use “None” and “Not done”


CRF Development
 Guidelines (con’t)
 Collect data in a fashion that:
• allows for the most efficient computerization

• similar data to be collected across studies

 CRF book needs to be finalized and available before an

investigator starts enrolling patients into a study

Take the time to get it right the first time


Elements of the CRF
 Three major parts:
 Header
 Safety related modules

 Efficacy related modules

 Module block of specific questions

 CRF module(s) make up a single CRF page

 CRF Book series of CRF pages


Header Information
 Key identifying Information
 MUST HAVES
 Study Number
 Site/Center Number

 Subject identification number


Creating Safety Modules
 Usually come from a standard library
 Select modules appropriate for your study
 Keep safety analysis requirements in mind
 Safety Modules usually include
 Demographic

 Adverse Events

 Vital Signs

 Medical History/Physical Exam

 Concomitant Medications

 Patient Disposition
Efficacy Modules
 Designed for each therapeutic area based on the protocol
 Considered to be “unique” modules and can be more
difficult to develop
• Use existing examples from similar protocols where applicable
• Consider developing a library of efficacy pages

 Design modules following project standards for data


collection
Creating Efficacy Modules
 Follow general CRF design guidelines
 Use pages or modules from the therapeutic library
 Define diagnostics required
 Include appropriate baseline measurements
 Repeat same battery of tests
 Define and identify
• key efficacy endpoints

• additional tests for efficacy


Importance of Standard
CRFs
Prepares the way for data exchange
 Removes the need for mapping during data exchange
 Allows for consistent reporting across protocols, across
projects
 Promotes monitoring and investigator staff efficiency
 Allows merging of data between studies
 Provides increased efficiency in processing and analysis of of
clinical data
CRF Development
Process
•Drafts CRF from protocol

CRF Designer • CRF Review Meeting


• Comments back to designer
Reviewers

CRF Designer
• Updates CRF to incl. comments
• Review and Sign off
• Coordinate printing and distribution
CRF Book Site
CRF Development Process
 Responsibility for CRF design can vary between
clinical research organizations (CRA, data manager,
specialty role)
• Include all efficacy and safety parameters
specified in the protocol using standards libraries
• To collect ONLY data required by the protocol

• Work with protocol grid/visit schedule


CRF Development Process
 Interdisciplinary review is necessary
• each organization has its own process for review/sign-
off
• Should include relevant members of the project team

involved in conduct, analysis and reporting of the trial


Begins
• As soon in the study prep process as possible
CRF Development Process
 Review Team (example)
• Project Clinician
• Lead CRA
• Lead Statistician
• Lead Programmer
• Lead Data Manager
• Others
• Database Development, Dictionary Coding, Standards
CRF Development Process
 After the CRF book is approved
 Initiate the process for printing

Note: the Protocol must be approved before the


CRF book is approved and printed
 After it is printed
 Stored according to organizational guidelines

 Printed and distributed to research sites


Properly Designed CRF
 Components/All of the CRF pages are
reusable
 Saves time
 Saves money

+
Poorly Designed CRF
 Data not collected
 Database may require modification
 Data Entry process impeded
 Need to edit data
 Target dates are missed
 Collected too much data – Wasted resources in
collection and processing
Poorly Designed CRF
Issues

=
The Case Report Form
 How do we use it?
• Collect data from the investigational sites
• Helps project team and study site team
• Reminder to investigator to perform specific evaluation

• CRA uses to verify protocol is being followed and

compare with source documents


• Biometrics uses it to build database structures, develop

edit checks and programming specs


The Case Report Form
 ...Used for
• Subject tracking

• Data analysis and reporting

• Reports to FDA on subject safety

• e.g.. APR

• Promotional materials

• New Drug Application submissions

• Support of labeling claims

• Articles in medical journals


Electronic CRFs

 The use of RDC is increasing


 In general, the concepts for the design of
electronic CRFs/RDC screens are the same
as covered for paper
 Electronic CRFs will impact the following:
 Review of CRF is different (screen

review)
 No need to print and distribute paper
Examples
Questions ?

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