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 the 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 Medication |
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 |