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

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
Abbreviations
  • AR – Access Rights
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Data Handling ↦ Database ↦ Access Rights
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Set-Up ↦ Data Handling ↦ Database ↦ Access Rights

Please note: the Easy-GCS tool is currently under construction.