Set-Up↦Data Handling↦Database↦Access Rights
What is it? Why is it important?
Access Right (AR) is the permission granted a user enagling him/her to read, enter, or change data in a given application.
The SP-INV is responsible to:
- Decide on allotted study database and CRF ARs
- Maintain a list of all staff members having current access to the database
- Maintain current and ongoing oversight of ARs at different sites in a multicentre study
Upon successful testing, database validation and the request by the SP-INV to release the database, the data manager:
- Switches the setting of the study database from testing/validation phase to productive mode, allowing for real-life data entry
- The productive database is an export into the productive phase without the inclusion of dummy variables (test data) entered during the testing phase.
- Based on delegated tasks, allocates personalised access rights to study staff
More
Study database access rights should be adapted and:
- Limited based on individual user rights (e.g. view only, data entry and change, data monitor and quality control, data manager responsibilities)
- Based on the degree of data confidentiality and on any risks associated with data leaks
- Granted according to applicable study site in a multicentre study. This requires that each participating study site only has access to its own data. Thus, access to data from other participating sites is not possible. An exception is the SP-INV who has access to data from all sites (participant identifiers excluded)
What do I need to do?
- Grant access to the study database only to staff members actively involved in the study, and who require access based on performance of delegated tasks
- Update access rights on a regular basis. Ensure only current staff or other current collaborating members have access to the database
- Deactivate user access as soon as a staff member leaves the study
- Maintain a list of ongoing access rights including names, date of access and date of access closure (keep the list in a secure and safe place)
More
In some studies, participants might be asked to enter data about themselves into the study database (e.g. daily diary, the timing of medication intake, adverse events).
In these cases participants are given access only to those parts of the CRF reserved for participant data entry. Participants can directly enter their own data into the CRF, but have no access or possibilities to view other data, including entries made by other participants.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 5.5. Trial Management, data handling, and record-keeping