top of page

Data Access Policy Overview


PSC Partners Seeking a Cure (PSC Partners) is committed to providing investigators and industry an opportunity to access the PSC Partners Patient Registry (Registry) data, and to assist in study recruitment while maintaining Registry participant privacy. Qualified non-profit investigators will be accorded Registry data without charge, while industry will be required to pay PSC Partners a license fee for the data to assist in covering some of the costs of maintaining the registry.

In making data available to investigators, PSC Partners is bound by its responsibility to guard the confidentiality of registry participants.

This policy provides information and guidelines for investigators and industry sponsors wishing to request access to de-identified patient data residing in the Registry. This policy requires that Registry data use remain ethical, purposeful and consistent with each original study proposal and request to access data.

Levels of Data

Four (4) levels of data can be requested by investigators and approved by the Registry Committee:

  1. Graphs of de-identified aggregate data. This data can be requested from the Registry Committee by emailing

  2. Case-by-case de-identified data. This level of data requires a project proposal, IRB approval or exemption and the approval of the Registry Director and the Registry Committee Chair. To be delivered on a password-protected speadsheet or csv file.

  3. Request for additional patient data through emailed questionnaire. This level of data requires a project proposal, IRB approval or exemption and the approval of the Registry Committee. [This is when the shared Registry data is insufficient and the investigator requests the implementation of their own survey.]

  4. Recruitment of registrants for clinical trials. Request to access individual subjects requires a project proposal, IRB approval and the approval of the Registry Committee. The Registry curator can perform queries based on the inclusion/exclusion criteria of a study and send potential subjects information about a study for which they may qualify.

    The Registry may provide the subject/caregiver a recruitment flier, informed consent form, and/or contact information for the site(s) conducting the study. Personal identifiers or subject contact information will not be provided to investigators. It is the responsibility of the consenting registry participants to contact the investigators.

Requestor's Responsibilities Regarding Data Use

  1. The specific purpose for the data use must be agreed to in writing by the investigator and his/her employer institution (“Institution”) or the industry sponsor requesting the material and the selected representatives of the Registry Committee including medical and patient representatives (Registry Committee) for the approval of the request.

  2. The investigator and Investigator’s Institution or industry sponsor (if any) must sign this Data Use Agreement, agreeing to abide by the Researcher Data Access Policy.

  3. The investigator must provide an electronic copy of an IRB approval, or for surveys, IRB exemption (see Levels of Data below), a study proposal including the specific aims of the study/clinical trial, and the name and qualifications of the research center. The rationale for selection of the population inclusion and exclusion criteria must be described in the project proposal. Other information may be required as requested by the Registry Director.

  4. The investigator and investigator’s Institution or industry sponsor (if any) must agree in writing that the data will be used only for the stated purpose and only by the requesting party and may not be passed on or shared with a third party.

    • (a) This Data Use Agreement is not transferable.

    • (b) Data will not be used to establish the individual identities of any of the subjects from whom data is obtained.

    • (c) Investigator, team, Institution and industry sponsors, if applicable, employees, and other research staff members must agree not to transfer data to any third party entity or any individual. The investigator, Institution and industry sponsor (if any) must agree that they will not sell or distribute the data and will only share the data with research staff members. The full team of individuals involved in the study are subject to the terms of the Data Use Agreement. The data may be used only for the time period specified in the approved request. Approval for access to the Registry data will be for an interval of no more than one (1) year from the date of approval, and Investigators must re-apply and submit a progress report to be approved by the Registry Committee in order to continue to use Registry data to recruit, or to continue to use the data for an approved study.

  5. The impact of research on people living with PSC is to be a key consideration for each project. Best ethical practices for ensuring the interest of the patient are to be applied.

  6. Any publication, oral and written presentations, or disclosures resulting from any and all analyses of the Registry data or based on the Registry data shall be subject to prior review by the Registry Director, must specify PSC Partners as the source of data, and are restricted to the scope of the approved study proposal. A copy of the final publication(s) must be sent to the Registry Director within 30 days of publication.

  7. Investigators, their Institution and industry sponsors accessing and using patient data must agree in writing to assume full responsibility for any and all uses of such data.

  8. Recipients of Registry data agree not to use it in advertising, publicity, or for purposes other than the purposes for which access to Registry data was granted, and not to use the logo, symbol, or other image of PSC Partners without its prior written consent.

Steps to Request Access to Data

​An investigator and industry sponsor will be permitted access to Registry data only after meeting the following requirements:

  1. Contact the Registry via email at The Registry Team will provide a Data Access Form and Data Use Agreement.

  2. Complete the Data Access Form confirming that the investigator and investigator’s Institution or industry sponsor and research staff will abide by the Data Access Policy.

  3. Provide a project proposal, including:

    • (a) ​Study proposal including the specific aims of the study

    • (b) Name and qualifications of the investigator(s); include the full research and team of all individuals involved in this study with their qualifications.

    • (c) Research center

    • (d) In the case of a clinical trial:

      • (i) Description of the procedures that will protect the confidentiality and security of Registry participants

      • (ii) Sample study recruitment letter

      • (iii) Consent form

      • (iv) Rationale for selection of the population inclusion and exclusion criteria should be described in the project proposal

    • (e) Disclosure of financial conflict of interest

    • (f) Description of the data being requested

  4. Provide IRB approval with the project proposal if the requested data involves de-identified case-by-case results, a request for additional de-identified data through an e-mailed questionnaire, and/or a request for participants for a clinical trial.

  5. Receive written approval of the Registry Committee if the proposal requests research access to the Registry data.

  6. Submit a declaration of interest (included in the Data Access Form and Data Use Agreement). This may be submitted following a positive review of the project proposal if so desired.

  7. In the case of surveys to all or selected Registry participants, coordinate with the Registry staff on both the timing and content of the email to be sent to Registry participants informing them of the opportunity to participate in the Registry Committee-approved survey.

If you have any questions regarding these policies or regarding the procedure to request access to Registry data, please contact us at

bottom of page