Clinical Trials Program

Before developing a proposal or submitting a joint application, collaborators should discuss and agree upon the following issues:

• Determine who will be the overall study Principal Investigator (PI)
• Delineate specific roles and expectations of team members
• Develop an adequate budget to cover all study-related costs
• Clarify data-related issues (e.g., access, storage, use, etc.)
• Determine authorship of study-related manuscripts
• Ensure appropriate confidentiality agreements are implemented
• Conduct any relevant activities preparatory to research using approved methods

There are several important issues in working with Kaiser Permanente that are related to data.

• When collaborative projects involve only KP patients, data or biospecimens, all related databases and specimens should remain at DOR and all data analyses should be conducted at DOR (providing DOR has the expertise) unless there is a compelling reason for a different arrangement.
• There are many collaborative projects, particularly those that are multi-site, and/or those requiring special expertise or extra resources, where sharing data with a collaborating investigator or laboratory is mutually beneficial and necessary for the conduct of the project.
• While often relevant information can be shared in aggregate, tabular, or graphic form, sometimes a sponsor or collaborator may be given a de-identified and limited dataset, or biospecimens for a particular group of KP members, if necessary.
• When data and materials will be shared with outside collaborators, how the data and materials will be used, stored, analyzed, maintained and presented publicly should be described in detail in a written agreement before funded work on the project begins.
• When limited datasets are transferred to an investigator outside of DOR, the outside collaborator must sign a Data Use Agreement (DUA) in advance, except in situations where the disclosure is explicitly described in either the patient consent/authorization or the IRB has approved a waiver of consent/authorization.
• When IRB approval expires, it formally signals the end of a project and of any ongoing analyses. At that point, materials must be returned and/or data certifiably deleted from the non-KP computers by outside collaborators. Specific research agreements may also allow earlier termination of the collaboration. All terminations lead to the return or destruction of materials or data.

The post-award responsibilities for PIs of funded projects consist of the following:

• Oversee all aspects of the project implementation, to ensure that the work is performed as detailed in the agreed-upon Scope of Work.
• Ensure that the project is reviewed at least annually by the IRB at both institutions or at only one institution if an agreement to cede authority was established.
• For clinical studies, ensure that all activities adhere to Good Clinical Practice guidelines and FDA Code of Federal Regulations (CFR) for FDA regulated trials.
• Ensure that adverse events are reported to the approving IRB as required.
• Ensure that spending is within budget and follows federal guidelines for allowable changes.
• If a subcontract PI, ensure that invoicing is accurate and timely for the project.
• Maintain frequent communication with your collaborator to ensure compliance with reporting requirements, financial monitoring, and other project management tasks.
• Ensure that all agreements are up to date, including: Subcontracts, Consulting Agreements, Data Use Agreements, and Material Transfer Agreements.
• Ensure that any transferred data are returned or destroyed at the end of the study as specified in the agreement.