What is an electronic case report form?

What is an electronic case report form?

An eCRF (electronic case report form) is a digital questionnaire that is used to collect data about a clinical study and research participants.

What is CRF in pharma?

Case Record Form (CRF) – Clinical Trial Medical Monitoring Plan | Online Clinical Research Courses In India.

What are EDC Systems?

What is an EDC system? To put it simply, an Electronic Data Capture (EDC) system is software that stores patient data collected in clinical trials. Data is typically first recorded on paper and is then transcribed into the system and saved in an electronic case report form (eCRF).

What is an ICF in clinical research?

The Informed Consent Form (ICF) is the main source of information to those considering participation in a clinical research study and is used to document a participant’s informed consent.

What is included in a case report form?

Case report forms contain data obtained during the patient’s participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient’s name, medical record number, etc., and giving the patient a unique study number.

Is a case report form a source document?

Case Report Forms Used as Source Documents Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.

What does CRF mean in research?

case report form
A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[1] Site personnel capture the subject’s data on the CRF, which is collected during their participation in a clinical trial.

Do case report forms need IRB approval?

Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.

What is included in case report form?

What is the purpose of an EDC?

Everyday carry (EDC) or every-day carry is a collection of useful items that are consistently carried on person every day. The main reasons for having EDC are utility and preparedness; to help individuals overcome simple everyday problems, including possible emergency situations.