The main tasks of the MDR are to ensure that the study data is complete, robust and consistent from a medical perspective. In that respect, MDR are involved in a series of activities which are starting at study set-up, throughout the study conduct phase and until the database freeze. MDR are key experts who participate to several meetings such as Study Core Team meeting, specific meetings with CRDL/Epi, Data managers to ensure proper planning, execution and control of the activities. In addition, they can be in contact with countries/study managers to solve Data Queries.
Study set-up activities
- Review the following study documents and provide input as described below
- Provide input to electronic Case Report Form (e-CRF) specifications and annotated Study Book:
- Compare the protocol and eCRF for the consistency
- Ensure the capture of the critical data related to the statistical endpoints defined into the protocol
- Provide input into integrated Data Review Plan (iDRP):
- Automatic/manual checks/queries
- Individual data listings
- Patient profile specification, if applicable
- Contribute to the development of eCRF completion guidelines driven by DM
- Develop Medical cleaning guidelines in collaboration with CRDL– living document to be finalized before the DataBase Freeze (DBF).
- Participate to the Cleaning Strategy and Timings defined by the Study Data Manager (SDM) under Oversight Data Manager (ODM) and in collaboration with the Safety physician
- Contribute to Monitors/Investigators meetings to ensure understanding of eCRF completion guidelines
- Contribute to the organisation of the Adjudication Panel reviews, if applicable
Study cleaning phase
- Help experts from Data management team to answer study/disease specific queries.
- Review checks generated by automatic cleaning in iDRP.
- In addition to automatic cleaning, perform manual cleaning:
- Review of subject data in the eCRF
- Review of Patient Profile (PP) by batch of subjects, if applicable
- Review of Medical listings including coding
- Perform consistency batch to align review on all data
- Review and perform quality control on elimination codes to ensure coherence across elimination codes attribution.
- Support SDM activities for elimination codes reconciliation
- Interact with Safety department for consistency between clinical and safety databases. MDR leads of meeting with Safety physician.
Set-up tools specific for the MDR role and used by Clinical R&D
- Tracking Tool (is used for the tracking of manual cleaning activities progress/timepoints and capturing of outstanding comments)
- Customize to the needs of the study/study design. Hence, it has to be developed for each study.
- Patient Profile (is an overview of clinical data reported, presented at subject level for manual cleaning and if needed, clinical assessment by external/internal panel of experts; contains relevant data captured, including endpoints impacting subsequent analyses)
- Developed and reviewed by MDR.
- Other applications for data storage (e.g. e-Clinipix)
- Customize the application together with DM expert.
- Perform User acceptance test together with Study Data Manager.
Adjudication panel, if applicable
- Review Data Transfer Agreement developed by Oversight Data Manager
- Perform Clinical data cleaning and reconciliation in case of use of other applications than eCRF
- In case of queries by external panel, post/follow-up queries to sites and highlights readiness for transfer of answer back to panel
End of cleaning
- Finalize the review of elimination codes
- Participate to the pre-analysis meeting (PAM) preparation:
- Data Management Report draft review by MDR for applicable codes
- Support for Stat check review if applicable
- Participation in Final PAM
- Provide manual and automatic cleaning listings to CDR for archiving
- Provide and approve cleaning guidelines