Department of Clinical Epidemiology and Biostatistics (CEB), Faculty of Medicine Ramathibodi Hospital, Mahidol University has introduced CEB data warehouse to utilize data to general researchers in and outside the Faculty for maximizing utilization of disease cohorts, facilitating scientific knowledge, and conducting research. The department formulated a policy and processes as a concern of data using must be responsible and must recognize legal, regulatory, and ethical constraints.
Scope
This policy covers all proposal applies for project collaborating and all researches retrieving/using data from CEB data warehouse. The policy developed under the concerns of maximizing the use of data while minimizing the risks of violating patient’s privacy with appropriately manage conflicts of interest. There are terms for the policy which are
Investigator: a person or team who request to use the data
Data sharing agreement: an agreement between the department and an investigator under the terms where the department agrees to provide an investigator a requested data for the purposes in the relevant ethical approved proposal
CEB data sharing coordinator: a person or group of CEB person who coordinate for the process of data using/analysis.
Consortium: a committee comprised of head of CEB department, clinical experts/epidemiologist, data scientists/biostatisticians who responsible for data access and sharing requests
Responsibilities of the investigators
The investigators are responsible for check topic if there are any on-going or done with manuscript publication in CEB website. If yes, the investigators may ask to join the on-going study or change the topic. If no, the investigators must develop a brief/full proposal with the available features provided in the cohorts. Then lodge the application by logging-in CEB data warehouse page, please see “Brief proposal and how to submit”. The initial review requires 20 working days, the consortium will provide (via email) the investigator with a request for clarifications, revisions, or approval. In the event that clarifications or revisions are requested, investigators must clearly demonstrate amendments made (track changes or highlight modifications) and respond via email. With the approval, the investigators should set the team (including at least 2 CEB project coordinators), develop a full proposal to apply for RAMA EC and other institute’s EC (if needed). The investigator has a responsibility to work with the EC to get the approval within 3 months, otherwise the topic of the approved brief proposal will be released from the CEB system. Once the ECs issue “EC approval letter”, the investigator must upload the approved full proposal with EC approval letter to CEB DW website, then start conducting the study.
Terms of sharing
- All data will be encrypted and used only for the objectives written in the proposal and must not be transferred to other research teams.
- Reference and funding information must be acknowledged : “Faculty of Medicine Ramathibodi Hospital, Mahidol University and “National Research Council of Thailand (N42A640323)”
| Data management and analyzing processes
