Scope:
Preparation of fundamental
clinical trial documents (protocol, case report form (CRF), informed consent
form (ICF), etc.)
Completion of patients’diary
Writing investigator’s brochure
Sub-centered summary & interim report writing
Clinic trial summary report
writing
During the screening of
hospitals, sponsors are required to provide basic contents of protocol by the
hospital. However, writing of protocol involves using a combination of clinical
trial regulation, clinical medicine and biostatistics, while experience in
operation and management of clinical trials are also needed. Generally
speaking, medical investigators are unlikely to grasp all the knowledge
mentioned above due to the hectic work.
A fairly good protocol
typically has the following requirements:
1. Ensure compliance with GCP
requirements, research guide and guidelines for diagnosis and treatment &
expert consensus
2. Manifest market
orientation of medical device
3. Save research cost &
shorten the duration of clinical trials relatively
4. Reduce the risk of failure
5. Help to provide updates on
the progress
6. Meet ethical requirements
Design principles of CRF
1. Reflect protocol
requirement for data collection
2.accord to investigators’ writing
habits
3. Regulate the filling requirements for different
types of data
4. Help to comprehend completion of CRF
5. Require multi-review
|
