Deposit Data
Are You Ready to Deposit Data to PCODR?
*Please note, data depositing is currently limited to PCORI Awardees.
Pre-Deposit: Calls can be arranged with PCODR staff to ask any questions you may have regarding what needs to be deposited and what preparations are needed to have files ready to deposit (guided by the Checklist for PCODR Data Deposit). A Data Contributor Agreement (DCA) (docx), will be shared with Awardees and must be signed prior to submission of the Draft Final Research Report (DFRR). A Data Sharing Kick-Off Call will be held with Awardees and PCODR staff after DFRR submission to review data de-identification and preparation of the Full Data Package for deposition.
DCA Submission Instructions: The DCA should be processed through the Participating Awardee institution’s appropriate channel (such as the office of general counsel) and a signed version should be sent to icpsr-help@umich.edu with the acronym PCODR in the subject of the message. If any edits are requested by the institution, please submit a tracked changes version of the DCA to icpsr-help@umich.edu with the acronym PCODR in the subject of the message.
Deposit: This stage begins once the DCA is signed, Awardees have submitted their DFRR, and the Data Sharing Kick-Off Call has been held. Awardees will upload their datasets and associated files using ICPSR’s secure online deposit form.
What are the Data Deposit Requirements of PCORI?
Awardees with awards to carry out a research project under any of PCORI’s various research funding announcements must be prepared to make the Full Data Package available as follows:
Full Data Package: The Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from a PCORI-funded research project.
| PCORI Funding Announcement (PFA) | Funding Cycle | Policy Expectations | Required Elements |
|---|---|---|---|
| Pragmatic Clinical Studies (PCS) | Cycle 1 2019 – Cycle 3 2021 | Required (all funded studies) | Full Data Package |
| Targeted | Cycle 1 2019 and after | Required (all funded studies) | Full Data Package |
| Broad1 | Cycle 1 2019 – Cycle 3 2021 | Not Required | Maintenance of Full Data Package for 7 years following the Final Research Report (FRR) acceptance |
| Broad Pragmatic Studies (BPS)2 | Cycle 1 2022 – Cycle 3 2023 | Category 1: Not required Category 2: Required Category 3: Required |
Category 1: None Category 2: Full Data Package Category 3: Full Data Package |
| Cycle 1 2024 and after | Required (all funded studies) | Category 1: Full Data Package Category 2: Full Data Package Category 3: Full Data Package |
|
| Phased Large Awards for Comparative Effective Research (PLACER) | Cycle 1 2019 and after | Required (all funded studies proceeding to full scale study conduct) | Full Data Package |
1– Broad (Cycle 1 2019 – Cycle 3 2021 [Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Communication and Dissemination Research; and Improving Healthcare Systems]): The Policy calls for maintenance of the Full Data Package for seven (7) years following acceptance by PCORI of the Final Research Report. In that time, PCORI may provide funds for the deposition of the Full Data Package to the PCORI-designated repository in circumstances where PCORI requests such deposition (e.g., due to PCORI estimate of high importance of research project findings or external research request).
2– Broad Pragmatic Studies (BPS) (Cycle 1 2022 and after):
- Category 1 – Research projects with direct costs up to and including $5 million.
- Category 2 – Research projects with direct costs greater than $5 million and up to a maximum of $10 million.
- Category 3 – Research projects with direct costs up to $10 million that utilize PCORnet® to conduct observational studies and/or pragmatic trials that are national in scale.
| Research Project | Cycle | Policy Expectations | Required Elements |
|---|---|---|---|
| Research Projects conducted using PCORnet® | Cycle 1 2019 and after | Required (all funded research studies conducted using PCORnet®) | PCORnet® Data Package3 |
3– PCORnet® Data Package Components: Full Protocol for specific research project; description of the PCORnet® Common Data Model tables, including ancillary or ad hoc tables (if applicable); all code used to query PCORnet® data; aggregate level dataset(s); aggregate results of any new or research-project-specific data quality investigations; and results from research-project-specific analytical queries.
Deposits of the full data package should include all data and documentation necessary for a data user to independently read and interpret the data
collection. Instructions for preparing data and documentation are listed below. For a discussion of best practices in preparing data for sharing, see
below for an overview and refer to ICPSR’s Guide to Social Science Data Preparation and Archiving
for more detailed information, and/or contact ICPSR-help@umich.edu
Where Can You Find Help with Depositing Data to PCODR?
- Checklist for PCODR Data Deposit (Word 46K) provides steps for preparing data for deposit.
- HIPAA Privacy Rule Checklist (Word 149K) provides tips for de-identifying data before deposit.
- Data Sharing Webinar [VIDEO] gives information on the PCORI Data Sharing Policy and a detailed overview of the Patient-Centered Outcomes Data Repository (PCODR).
- Demonstration of ICPSR’s New Data Deposit System [VIDEO] provides a quick tutorial on the online tool for depositing data.
- Data Deposit Roadmap provides an overview of the steps from pre-deposit through post-release of the data.
- Frequently Asked Questions include FAQs for PCORI grantees depositing data into PCODR.
- Additional help is arranged by contacting ICPSR-help@umich.edu with any questions about depositing.
What Happens After You Deposit Data to PCODR?
After you submit your data to ICPSR:
- Pre-Acceptance: The data package will be reviewed to determine completeness. Staff will contact submitter regarding missing pieces or with any remaining questions. Once corrected, the data package will be approved as complete by PCODR staff and PCORI.
- Data Curation: The data package gets a study description, the information in the data package may be organized or improved, and the data package undergoes a series of quality checks.
- Data Preservation: Curated data packages are ingested for long-term preservation where it is stored in accordance with prevailing repository standards and practice. For example, quantitative data files are preserved as ASCII format along with setup files for the statistical software packages, and documentation is preserved using XML and PDF/A.
- Data Release: Information about the availability of the curated data package is published to the repository catalog. PCODR data packages require all requests are reviewed and approved users are then required to enter into a restricted-data use agreement. Data packages containing quantitative data are made available in several widely used formats, including ASCII, tab-delimited (for use with Excel), SAS, SPSS, and Stata. Documentation is provided as PDF.