Questions and Answers (Q&A)
How many participants do you have in the Registry?
As of May 2013, there are almost 43,000 Registry participants (adults and children). Approximately 35,000 Registry participants are UPMC patients recruited from participating clinical outpatient offices and UPMC HealthTrak. The remaining participants are recruited from the general community in Western Pennsylvania via outreach events and the Registry website.
Is there a charge to use the Registry to recruit participants into my study?
No. There is no charge to use the Registry. However, for industry-sponsored trials, the investigator must obtain sponsor approval (in addition to IRB approval) before they can use the Registry to recruit. Proof of IRB (and sponsor, if appropriate) approval must be provided to the Registry Administrator before any study can be added to the Registry database.
Once my study is included in the Registry, will I have access to lists of Registry participants who may qualify for my study?
No. Any participant contact regarding studies is initiated either by the Registry Office or by the participant.
How do participants find out about my study?
Participants in the Registry receive a quarterly match letter that contains five studies for which they might be eligible based upon demographics, ICD-9 diagnosis codes and participant-chosen health areas of interest. When investigators add their study to the Registry, the inclusion/exclusion criteria for their study are “modeled” using ICD-9 diagnosis/billing codes that are then matched to the ICD-9 codes in the UPMC Registry participant’s medical record. Community Registry members will also receive the study in their letter if they choose the health area of interest that is relevant for the study (ex., smoking = Wellness and Lifestyle, Parkinson’s Disease = Brain and Nervous System, asthma = Lungs and Breathing, etc.).
What happens once a participant receives a match letter?
If a participant, or parent of a minor participant, is interested in a study or studies in their letter, they have to call into the Registry Screening Office to be pre-screened for the study. If a participant passes the pre-screen and gives permission to have their information forwarded, their name and telephone number are then sent to the study coordinator. NOTE: Pre-screening questions are added as part of the “modeling” process for the study. The screening questions can be updated or edited at any time by the study staff.
How do I include my study?
For studies reviewed by the University of Pittsburgh Institutional Review Board (IRB):
When submitting your protocol or modification through OSIRIS, select the CTSI Research Participant Registry as a recruitment method in Section 4.1. No other changes are required.
For studies reviewed by external boards:
If you are conducting a study that is not under the purview of the University of Pittsburgh IRB, you can still use the Registry to recruit. In the recruitment section of your protocol, please indicate that you are planning to use the Registry as a recruitment tool (suggested language: “We are planning on using the University of Pittsburgh CTSI Research Participant Registry as a recruitment tool.”). What should I do once the IRB (and sponsor, if appropriate) has approved my use of the Registry? Once your study has been approved by the IRB of record (and the study sponsor, if appropriate) to use the Registry, send an email to firstname.lastname@example.org or call 412-864-3478. A Registry staff member will begin the process of adding your study to the Registry database. You will have the opportunity to approve your study information, including ICD-9 codes and screening questions, before the study is added to the Registry database. What types of studies should be included in the Registry? Any IRB (and sponsor, if appropriate) approved study recruiting human research participants (children and adults) that is being conducted at the University of Pittsburgh or UPMC. What are my obligations if I use the Registry? Investigators and/or coordinators must: