Medical review is the core activity throughout the life cycle of the clinical study that will ensure the safety of the patients and the integrity of the data. It mainly comprises of periodic data review activities and ad hoc medical assessments.
Depending on the size and complexity of the trial Medical Review will be performed by 1 or more personnel (usually named Medical Monitors). Medical Monitors usually are physicians of the same or similar specialization as the disease area under study but may also be a combination of physicians and/or clinical scientists with deep expertise in the area.
1. Medical Review Plan
As with ALL activities in a clinical study proper planning is key. As such development of a study specific Medical Review Plan (MRP) will ensure that all related activities are clearly outlined. The main feature of an MRP is a table of medical data checks to be performed throughout the trial. Each entry explains briefly the nature of the check to be performed (e.g. cross checking the Medical History of the patient with concomitant medications received to detect any potential inconsistencies), the source of the information (e.g. eCRF, Data Listings, Medical Review Platforms etc.) and the frequency of the review. Certain data checks may be performed automatically through algorithmic checks and other manually by the Medical Monitor. Such detail must also be clarified in an MRP.
2. Medical Review Medium
Depending on the study and budget of your trial there are various ways to perform Medical Review from check all information in the eCRF to performing complete Medical Review in specialized online data visualization platforms. If a Medical Review Platform is not available, then data listings should be preferred over simply reviewing data in the eCRF. Such listings should have the functionality of being updated periodically with flags of new unreviewed data, reviewed data and modified data.
The key to ensure an efficient review process is to clarify from the very beginning the scope of Medical Review and piece it closely together with all other data cleaning activities, especially Data Management related ones. Medical Monitors and Data Managers shall be in very close collaboration to ensure smooth cleaning of the study data. It is the Data Management department that will provide any necessary Data Listings (mentioned before). Data Management will also be responsible for tracking the status of any medical queries that have been opened in the system. So regardless of the platform where Medical Review is undertaken, clear and frequent communication with Data management is of outmost importance.