What is it? Why is it important?

Access Right (AR) is the permission granted a user to read, enter, or change data in a given application.

In a study, the SP-INV is responsible to: 

  • Decide which staff member is granted access to the study database, enabling them to make entries and make changes to the study data. AR can be personalised, with some members only able to read entries, while others able to both enter and change its content
  • Maintain a list of all current staff members having access to the database, and ensure that persons who are no longer part of the study team have their AR removed
  • Maintain current and ongoing oversight of ARs at different participating study sites (e.g. multicentre study)



In a study, AR should be:

  • Customised based delegated study tasks (e.g. view only, data entry and change, data monitor and quality control, data manager responsibilities)
  • Based on degree of data confidentiality, with selective access to different areas of the study database (e.g. restricted access where each participating study site only has access to its own data, restricted access to the randomisation list in a blinded study)


The SP-INV should always retain access to all study data.

What do I need to do?

As a SP-INV:

  • Grant access to the study database only to staff members actively involved in the study, and who require access based on the performance of delegated tasks (e.g. staff delegation-log)
  • Update ARs 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 ARs including names, date and type of access and date of access closure. Keep the list in a secure and access protected place


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 database reserved for participant data entry. Participants can directly enter their own data into the study eCRF, 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


ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
  • AR – Access Rights
  • CTU – Clinical Trials Unit
  • eCRF – electronicCase Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Data Handling ↦ Database Set-Up ↦ Access Rights

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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