Electronic Data Records Flashcards
- To understand the principles of Case Report Forms. - To evaluate different sources for data collection. - To identify methods of data collection in clinical trials.
What are the source documents?
The original document on which the information was first captured.
What are some examples of source documents?
Written medical notes, electronic patient records, questionnaires, lab test results, ECGs.
What is source data needed for?
To allow the trial to be reconstructed and to provide an audit trail for monitoring.
What does ALCOA stand for?
All source documents should be:
A - Attributable
L - Legible
C - Contemporaneous
O - Original
A - Accurate
What is a case report form?
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”.
What data do CRFs contain?
CRFs only contain pre-defined data required for use in the clinical trial. This allows for a standardised set of relevant data to be produced for all participants in the trial.
What are the hallmarks of a good CRF?
It should avoid duplication, be self-explanatory, easy to complete and aid in transcription of data to the electronic data capture (eDC).
What details should be on the CRF?
The header should contain the protocol version and date, the site number and the participant’s ID, initials and date of birth.
The footer should contain the researcher’s signature/initials, the date and the CRF version number.
What are the pros and cons of different types of CRFs?
Paper CRFs - useful for small trials, are quicker to design but result in many more edits and many sheets of paper.
Electronic CRFs - useful for larger, multi-site trials, are easier to audit and better for the environment but require effort to set-up, technology, investment and maintenance.
What is the eDC?
The eDC allows for data to be transcribed and uploaded from CRFs for access by the sponsor and independent monitors. It also allows for queries and cleaning of data for analysis.
