Section 1. Key Roles and People Involved
Section 1 outlines all the personnel who have been or will be involved with the project. Every application has a number of Key Roles which must be filled. These are:
- 1.1 Applicant
- 1.2 PhD Supervisor* see below
- 1.3 Clinical Sponsor/Lead
- 1.4 Information/Data Custodian
*Section 1.2 only needs to be completed if your study will form part or all of a student research project at any level of study. In such cases Student Supervisor is another Key Role. Students cannot take on the roles of information/data custodian or clinical sponsor. Anyone in a Key Role (1.1-1.4) or who will access the data for analysis (1.5) must provide proof of having completed PBPP-approved IG training within the three years prior to submission, before the application can be submitted.
1.1 Applicant
This is the person with operational responsibility for the proposal. If you are filling out the application form, this is you.
1.2 PhD supervisor * see above
This is required if the applicant is a PhD student
1.3 Clinical Lead / Sponsor
The clinical sponsor or lead is a senior clinician / Head of Department / Principal Investigator with overall clinical responsibility for the proposal.
1.4 Data custodian
The information or data custodian is the person with responsibility for safeguarding the confidentiality of data throughout the proposed work and should have training in Information Governance. An information custodian is a senior colleague with a key role in any proposal and is always required to be named in an application.
1.5 People accessing patient level data*
*if data is considered pseudonymised, the data still counts as personal data (even in a Safe Haven) and subject to GDPR.
This will include those who are processing data on your behalf (for example in research safe havens or linkage agents).
1.6 Others involved in project (not accessing data)
This might include colleagues who will be accessing aggregated tables, interpreting study findings, or providing strategic direction.
NOTE – 2.2 Main Contact for Lead Organisation
This person should not be the Applicant, Clinical Sponsor/Lead, Data custodian or anyone from within the research team but someone who is able to assure the organisation’s role in the project. This role is to ensure organisational accountability for the data and therefore this role should not be filled by anyone involved in the study.
Links to the other sections
Section 2: Organisations & Bodies
Section 3: Overview
Section 4: Data, Data Subjects and Methodology
Section 5: Safe Data Processing and Security
Section 6: Outputs and Dissemination
Section 7: Declaration
Here is an example of a completed PBPP Application using fictional data.
Back to How to Apply
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