The Registry of Patient Registries (RoPR) Thomas Taylor, Senior IT Project Manager, Quintiles Michelle B. Leavy, Research Manager, Quintiles
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1 The Registry of Patient Registries (RoPR) Thomas Taylor, Senior IT Project Manager, Quintiles Michelle B. Leavy, Research Manager, Quintiles February 10, 2014
2 Posting a Registry Profile on the RoPR
3 What is RoPR? The Registry of Patient Registries (RoPR) is: A searchable central listing of patient registries Similar to ClinicalTrials.gov, but designed specifically to collect data relevant to patient registries Funded by the Agency for Healthcare Research and Quality (AHRQ)
4 Definition of Patient Registry for RoPR A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s). The registry database is the file (or files) derived from the registry. Note: The RoPR definition was adapted from the definition provided in the AHRQ publication, Registries for Evaluating Patient Outcomes: A User s Guide, to be inclusive of registries that are not used to evaluate patient outcomes. See Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User s Guide. 2nd ed. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No. HHSA I TO3.) AHRQ Publication No.10-EHC049. Rockville, MD: Agency for Healthcare Research and Quality. September 2010.
5 RoPR Objectives Primary Objective: Promote collaboration, reduce redundancy, and improve transparency in registry research Secondary Objectives: Encourage and facilitate the use of common data elements and definitions in similar conditions Provide a central repository of searchable summary results Offer researchers a search tool to locate existing data to request for use in new studies Serve as a recruitment tool for researchers and patients interested in participating in patient registries
6 Defining Your Registry What does your registry cover? Disease/Disorder/Condition Product Drug Transplant Pregnancy Service Encounter Tumor Product Biologic Service - Hospitalization Vaccine Product - Device Service - Procedure Other What is the purpose(s) of your registry? Clinical Practice Assessment Payment / Certification Quality Improvement Effectiveness Post Marketing Commitment Safety or Harm Natural History of Disease Public Health Surveillance Other Why would you want to be contacted about your registry? Collaboration Data Access Enlist Investigators Enlist Participants (Patients) More Information Other What is your registry s geographic scope? Single Institution / Practice State Regional National Global
7 Posting a Registry Brief Overview 1.Register the registry in ClinicalTrials.gov 2.Select observational study as the study type. Check the box to indicate that the study is a patient registry 3.Click to complete the registration in RoPR 4.Enter remaining data elements in RoPR and submit for posting
8 Posting on the RoPR Data elements defining a Registry Profile overlap with fields on ClinicalTrials.gov, run by NLM Rather than duplicating content, the RoPR is integrated with ClinicalTrials.gov. Posting on a Registry Profile involves posting NLM s Protocol Registration System (PRS) in order to gain access to the RoPR Registration System (RRS). To request PRS account, refer to:
9 Defining a Registry in PRS Step 1 Login Step 2 Open the record
10 Defining a Registry in PRS Step 3 Define the Study Type Note: In order to gain access to RRS, you must select Observational Study Type and use the Patient Registry check-box
11 Defining a Registry in PRS Continue to populate data throughout all sections In the Study Design section, click the link provided to access RRS:
12 Defining a Registry in PRS Once populated, RRS can also be accessed via the PRS Protocol Record Summary.
13 Defining a Registry in PRS Populate the remaining PRS content. Ensure that the record is approved and released. Note: NLM conducts quality review of all records before they are made public on ClinicalTrials.gov. AHRQ and the RoPR team has no say in the management of ClinicalTrials.gov data
14 RRS General Features All data in the RoPR are meta-data about the registry; no registry-specific information is disclosed in the RoPR. All RRS pages have a navigation pane on the left side of the screen. A Completion Status bar at the top of the page displays progress by the number of data sections. Required fields are indicated with a red asterisk Error messaging displays in-row, and is dynamic. Data definitions are available by clicking field labels.
15 Overview Page The Overview is the landing page. Other than the user s , used only for administrative purposes, no data are entered here. Help documentation and XML upload is available on the Overview.
16 Registry Description The Registry Profile s Title and geographical area are collected on the Registry Description. Brief and Long Description fields are imported from the ClinicalTrials.gov record once it s posted.
17 Registry Classification and Purpose Information defining the nature of the registry is collected here.
18 Contacts and Conditions of Access This page is where Registry Holders can indicate their interest in being contacted for information about the registry and provide RoPR users with the means by which to contact them.
19 Progress Report The Progress Report allows for the display of update information about the registry (e.g.: annual reports). Multiple Progress Reports are supported. Progress Reports are not uploads to the RoPR; however external links may be provided
20 Related Information This page allows for the posting of external links that may be relative for the registry. Multiple links are supported.
21 Outcome Measures Conditions Derived from MeSH, define the high-level conditions covered by the registry. Multiple options may be selected.
22 Outcome Measures - Categories Categories represent what types of data are collected in the registry. Categories can include standards, scales, instruments, and measures utilized by the registry.
23 Preview A Preview page is available, presenting the Registry Profile as it will appear on the RoPR Search Site. Tip: the icon can be used to navigate back a data section for updates.
24 Save / Release The final page, Save / Release Registry Profile, features a confirmation check-box and options to either save the data or release it to RoPR Search. A released Profile will be published within 24 hours. To return to a saved Profile, re-access the record via PRS
25 Why Should I Register My Registry in RoPR? From a voluntary perspective, registry owners might be motivated to participate in the RoPR in order to. Be transparent Seek collaborators for their registry Aid in recruitment of patients and providers to their registries Market the availability of their data assets for use or collaboration Ensure the continued use of the data for the public good even when the registry otherwise ends 25
26 Register Your Registry Register your registry in the RoPR at: For background information about the RoPR: ch-for-guides-reviews-andreports/?productid=690&pageaction=displayprod uct. 26
27 Questions? Tom Taylor Michelle Leavy RoPR Project Team
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