Methods of Capturing the data clinical trials.
When researchers conduct a clinical study, they collect information about their patients using Case Report Forms (CRFs).
After the conduction of clinical Trials or BA/BE studies the large numbers of forms like CRF, Protocol, ICD, Insurance Policy, Source documents, Master documents were required for the study as well as the Audit purpose for the regulatory.
During the Conduction of the study data should be captured in the paper format or Forms manfully filled by the user and there is the possibility of mistakes or forgot the operational activity entry during the operational activity.
What Electronic Data Capture (EDC) Gives:
- It is Used For conduction of clinical Trials or BA/BE studies
- Electronic Data Capture (EDC) gives the benefits of Electronic Capture Data in Electronic format.
- Provide data accuracy of data
- Can Design the CRF and Other activity forms
- Data Stored in individual project code section
- User-friendly interface and operating the software
- No paper use will reduce the cost of paper and avoid the error also
- Every User have individual access of computer system
- Easy and Secure data and Access
- Access for the proactive support from the technical team to set up the clinical trials
Benefits by using Electronic Data Capture (EDC):
- It is easy to set the New Clinical trails as well as project management
- Handle the data of complex study easily
- Secure access for individual user
- Data Capture with high-Quality & Error free
- Reduction of cost of human & Paper
- Have the Access to the review of QC/QC to avoid the error during the submission
- Design can be copied and Reused for the future project
- By Using this can Manage Adverse Event, SAE, eCRF Data
- 21 CFR Part 11 Compliance
- Design As per the ICH-GCP E6