As per ICH-GCP Guidelines, Case Report Form is “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.”
Case Report Form is primary tool used by the sponsor and made by the help of protocol to capture all the patient data from all sites. Case Report Form always designed in such manner that a lay men can easily understand and fill it without any objections. In most of the case where language create an issue or barrier in that situation CRF is designed in multilingual forms.
Case Report Form are in both paper and electronic form, in many organization coordinator of the site first capture all the data into paper CRF and then same coordinator or data management person upload all the paper CRF data into electronic CRF and store into server for multi-site access.
In most of the case sponsor gave the complete contract for CRF designing but in some case sponsor design the CRF from in-house staff. CRF is designed and based on protocol, CRF designer first read the protocol and then check the points and include them into CRF. In that way sponsor can easily analyse that which data is important on the basis of study outcome results.
Advantage of eCRF
As I said previously, In most of the organizations CRF is filled in Paper form. But now by the help of tabs and other new instruments CRF is directly filled into Electronic forms. This way has many advantages:
- Efficient and faster
- High security
- User and environmentally friendly
- Cost effective
Purpose of CRF in Clinical Trials
As per my above description about CRF, you aware about why we use CRF in Clinical Trials. Below points will give you complete idea of purpose of CRF in clinical trials:
- Data collection in a specific format
- As per protocol requirement
- Comply with regulatory requirements
- Efficient and complete data collection for processing, analysis and reporting
- Data exchange across the projects and organizations esp. through standardization
Some studies are operated for few months and some for years. So in that case CRF pages ranges to hundreds of pages in paper and electronic forms. The important thing in CRF designing is, we divide all page in two divisions. First are unique pages and second are non-unique pages.
Unique Pages :
Those pages which collected same type of data each time that are called unique pages. Suppose a page contain options like Date, patient ID, Age, Gender etc. If all these options are in single page then this is called Unique Page.
The Opposite of unique Pages is called non-unique pages in which pages included in single time during the study or page have some extra options are included in non-unique pages.
Protocol – CRF Relationship
- Protocol determines which data is important and should be collected in CRF
- All per protocol all data must be collected, don’t leave any point from protocol
- As per analysis point of view, if any data will not be analysed then don’t collect that data in CRF