This is a web-based tool used at Investigator Sites to record, store and manage clinical study data. This process allows the Investigator and Sponsors to view clinical data directly at time of entry, address any discrepant data as needed and sign or approve electronic case report forms (eCRFs). With the invention of this process, the Clinical Research Associate (CRA) can view or audit the date or the document from the other site as well. He doesn't has to come at the site. He can inspect from whenever he wants to.
The workflow of the RDC (Remote Data Capture) process is as follows:
At the trial site, data is entered in eCRF by the investigator or Clinical Research Coordinate (CRC). The data is entered in the system or database by the database programmer. After this, discrepancies are generated either by the system or by the user i.e. CRA or Monitor who is the representative of sponsor. The validation checks are used to resolve the qury or discrepancy. The coordinators or CRC rectify or clarify the discrepancy generated in the eCRF. The changes are approved and confirmed by the investigator. He is the one who gives the final say. The CRA or Monitor review the changes or comments. The changes are either rejected or accepted. If it is rejected it has to verified again by the investigator. The discrepancies are closed bt the system, CRA or data management team. CRA performs Source Document Verification (SDV) and verifies the eCRF. Now the clean data is analysed by the statisticians. Then finally the data is locked or freeze.
Now, lets focus on the responsibilities of different people involved in the process of RDC.
1. Study Coordinator - who helps the investigator in performing different tasks during the trial at the site. He enters the data in the eCRF by interviewing the subjects/ patients. He review and respond to the discrepancies generated by the system or user and also enter the investigator comments in data field whenever required.
2. Investigator- the medically qualified physician or doctor who administers the subject during the trial and in the follow up period. He is the one who determines the outcome of the investigational product. He inquires the subject and enter the data in the eCFR. Review and respond to the discrepancies. He approves the eCRF Casebook.
3. Clinical Research Associate (CRA)- he is the representative of the sponsor. He reviews the data and create manual discrepancies whenever required. He trails the complete eCRF. He advise or write the comments for the site Coordinator with discrepancies and queries regarding the data. He performs the Source Document Verification against the eCRF and close the discrepancies.
4. Data Management Team- the people who are involved in the database programming and collection of all the eCRFs from the trial site. They review and perform cross checks of data and generate manual discrepancies wherever required and issue the Data Clarification Form (DCF) to be reviewed by the investigator. They lock the clean eCRF and finally freeze the database.
5. Technical Environment- the technicians involved in the whole process of RDC. They design the whole RDC system security and infrastructure requirements at the site and provide hardware setup and training.
6. Operational Environment - people involved in the operational work. They establish site based discrepancy management specifications. They also provide site based data entry and discrepancy resolution training.
7. Support Environment - these are the setup technical support, like help desk.
The system without any merit is meaningless. So, here's the brief about the advantages about RDC. It improves the overall data quality by allowing :-
I) The Sponsor to have real time access to the data.
II) Discrepant data to be immediately identified and resolved in a timely manner.
III) CRAs' to monitor site data remotely and prepare for monitoring visits.
IV) Dependence upon the paper system is minimized which came as a great relief.
Though, nothing comes with all good. There are some demerits associated with this system as well and they are as follows:-
i) 24 hours internet facility is required even at the remotest site where power supply might be a big problem.
ii) Technical or IT support is always required.
iii) Every staff member at the site i.e from investigator to the coordinators and sub-coordinators must be trained.
It is well known that to achieve something we have to pay for that. So these minor faults can be resolved and this system must be utilized everywhere to make the task of data management easier and flawless.
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