What is a CRF
Each clinical research has its CRF. It makes it possible to collect all the necessary data for a thorough study and monitor its completeness. CRFs are completed by the organizations conducting the research. The input only true facts and numbers about the patients.
The info contained in the CRF must be accurate, complete, current, and legible, and consistent with the original doс (e.g., medical history, original printouts of additional test results, etc.).
Note that the development of such documents requires a professional approach. It makes it easier to analyze the info obtained during the research. We, therefore, recommend that researchers commission the exclusive eCRF design.
A CRF is a paper or electronic document that collects all data about each participant and info about the occurrence of side effects. It sends the collected data to the trial sponsor. Patients’ personal information is not given, like their names or other identifying information. It uses randomization codes.
CRF — a unique document in which data related to a clinical trial are collected from sources (e.g., medical history, laboratory results, diagnostic imaging results).
All data included in the card must be obtained from medical doс and verified by an independent verifier. CRF is one of the mandatory documents that make up the clinical research doс submitted to the appropriate committee authorizing the study.
Providing eCRF for Research
The eCRF system must be FDA-compliant and customized each time for specific research. Use of the software does not require the purchase of a separate license. The availability of modules such as audit trail, data queries, randomization, drug management, dynamic reports and statistics, adverse event reports, notifications/alerts, online contracting, and commentary make the system valuable and attractive to specialists.
In addition, modern clinics must provide acceptance testing, full validation, and data services.
What is the Purpose of the CRF?
The purpose of the CRF is to:
- Ensure that the protocol can collect data;
- Ensure compliance with regulatory requirements;
- Facilitate efficient and comprehensive data processing, present results, and exchange data between the research team and sponsor representatives.
What should the clinical observation card contain?
The card should contain elements such as:
- research name and number;
- name of the principal researcher;
- Subject’s data;
- demographic data;
- A detailed description of medication dosage;
- concomitant treatment;
- definition of side effects;
- conclusions about the patient’s health status.
Additional CRF elements are:
- the patient’s previous medical history;
- previous procedures;
- primary and secondary diagnoses;
- laboratory researches;
- description of research procedures;
- evaluation of efficacy endpoints.
The electronic version of the CRF is subject to the rules described in the FDA doс. In addition, validation is performed by the Clinical Trial Monitor (which works for the CRO). The monitor has to compare the original doс at the site with the CRF data researchers. If there is a discrepancy, the monitor makes inquiries, to which the researcher has to respond.
Currently, more than 70% of clinical trials use an electronic clinical control record (eCRF), i.e., an organization inputs medical data into a computer program designed for this purpose. The most modern solutions are cloud-based programs with multi-access.