Protocol and CRF Development

CCRB has acquired the experience to create optimal study designs and develop protocols and case report form for research programs that extend from dose-finding safety and efficacy studies to large sample-size registration trials. Our personnel have the experience and the knowledge in all areas of clinical research, biostatistics, and regulatory issues to lead the design of your study as required. Our protocol and CRF development services are governed by rigorous SOPs and comply with ICH GCP guideline. The following are required elements of protocol and CRF. Other elements will be added on a trial-by-trial basis:

Elements of Protocol

Element of CRF

General Information

Elements on Each CRF Page

Background Information

Protocol Number

Trial Objective and Purpose

Space for Subject ID or/ and initials

Trial Design

Appropriate Heading

Selection and Withdrawal of Subjects

Visit Number

Treatment of Subjects

Date of Visit

Assessment of Efficacy

Page Number

Assessment of Safety

Statistics

Element in CRF

Direct Access to Source Data Documents

Inclusion and Exclusion criteria checklist

Quality Control and Quality Assurance

Demographic Data

Ethics

Physical Examination

Data Handling and Record Keeping

Medical History

Financing and Insurance

Vital Sign

Publication Policy

Concomitant Medicaiton

Supplements

Record of Efficacy Parameter

Record of Safety Parameter

Label(s) of Test Article(s)

Record of Adverse Events

Reasons for Withdrawal

Reason for Breaking the Blinding Code

Investigator’s Signature Page