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Data Management Reviews
The Quality Assurance program conducts data management reviews (DMRs) to ensure compliance with sponsor requirements and verify that University policy RP15 is being followed. Any study for which data is being collected and stored is eligible for a DMR to confirm RP15 expectations are being followed. However, emphasis is placed on studies required to have a Data Management and Sharing Plan (DMSP) per funder or sponsor requirements.
DMRs assist researchers in meeting requirements and expectations for data management, and provide an opportunity for investigators and their study team to ensure that they are adequately following their approved data management plan and to determine if any modifications are needed. Aside from ensuring that DMSPs are being followed, the goal of the Quality Assurance team is to proactively assist researchers and identify issues of potential non-compliance, and to offer an educational opportunity for researchers to better understand funder and institutional requirements as related to their DMSPs.
Although not punitive in nature, failure to cooperate in the data management review process is a violation of University Policy, and observations of non-compliance will be subject to escalation up to and including funder notification. For more information and background on the development on the University’s data management policy, please see Research Data Management Policy – Research Support
For researchers looking for guidance on how to draft a data management plan, the following University resources may be of use: DMP Basics – Data Management Plans – Library Guides at Penn State University.
Routine DMRs
Routine DMRs involve a virtual meeting with the Quality Assurance team to discuss their audit of the researcher’s approved data management and sharing plan and to ensure compliance with funder regulations regarding data management and sharing. While DMR selection is mostly random, the QA program takes the following into consideration to ensure a wide variety of studies are included in these audits:
- Funded research
- Studies involving human subjects
- Studies selected for a post-IRB approval review
- Amount of award
- Length of study
- Sensitivity of data
- Previous noncompliance
- Referrals from other units and/or the Institutional Official
Review Preparation
To help investigators and study team members, Quality Assurance will share an agenda prior to the meeting. To prepare for the review, PIs and study team members should know where to access and/or be aware of the following information:
- Types of data collected
- What data has been stored
- Data retention timeline and procedures
- Data curation process
- Plans for data access and data sharing
Typically, the meeting is with just with the PI, the PI and the project coordinator(s), or only the project coordinator(s), however, the PI can invite whomever they would like to attend. Because the of need to verify the identity of the individuals present and/or participating in the meeting, there is an expectation that cameras will be turned on. Alternate arrangements may be made at the discretion. If prior notice is not given, the meeting may be rescheduled.
Meeting Summary
Each Data Management Review (DMR) concludes with a communication to the Principal Investigator (PI), documenting the review outcome. If no issues are noted, the PI will receive an email summarizing the review and confirming that no further action is required. If findings are present, the PI will receive a memo outlining the findings and any required actions, such as updating and resubmitting the data management plan to the sponsor. Investigators will have the opportunity to review and comment on the memo prior to its finalization. If findings are identified, the Quality Assurance team may share the finalized memo with University officials or sponsors as appropriate.
Abbreviated or Self-Assessment Reviews
Any studies that have a data management and sharing plan may be selected to complete an abbreviated data management review at random. Abbreviated audits require that investigators complete a brief form answering questions related to their data management practices. If selected for an Abbreviated Audit, the investigator will receive an email along with a completion deadline. The PI may delegate completion of the form. Depending on the answers provided, the QA team may ask for additional clarification.
Similar to the Abbreviated Audit Form, the Self-Assessment Form asks questions to help researchers proactively assess their data management and sharing practices. Researchers can complete the Self-Assessment Form at any time.
Office for Research Protections
Address
200 Innovation Blvd.
Suite 110
University Park, PA 16802
The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.