Frequently Asked Questions

If you cannot find the answer to your question, please contact reliance.team@reliance-study.org

I. General

1. What institution is the lead site for the Phase 2 IRB? (Updated May 2019)

The University of Illinois at Chicago is the Prime awardee and the lead site for the Phase 2 IRB. Johns Hopkins University is the data coordinating center for RELIANCE.

2. What institution is the data coordinating center for RELIANCE? (Updated May 2019)

Johns Hopkins University is the data coordinating center for Phase 2 of RELIANCE.

3. Where can I find my site's landing page and landing page password? (Updated May 2019)

An email with your site's landing page and password was sent to your site PI. If you need your information resent please contact us at reliance.team@reliance-study.org.

4. Someone new joined our team, how do I make sure they receive RELIANCE trial meeting
          invites and emails?
(Updated May 2019)

The RELIANCE team’s distribution list is generated directly from your contact database, which you can access and update on your site’s landing page. RELIANCE Steering Committee calls, Memos, general email updates, Office Hours, and Coordinator call communication will be sent to those listed as PI, Co-I, Coordinators, and Additional Contact. To update your contact list please go to the 'Update contact information' tab on your landing page.

5. What if my patient is already enrolled in the AIRWISE COPD study? (Updated May 2019)

RELIANCE allows concurrent enrollment in other clinical trials. If your patient is participating in the AIRWISE study, they can still be enrolled in RELIANCE. We recommend you confirm concurrent enrollment with study administrators for the AIRWISE study.

See PDF for a comparison of the RELIANCE and AIRWISE COPD study.

6. What role is the FDA playing in the trial? (Updated June 2019)

The Sentinel System is the FDA’s active safety surveillance system and uses routine querying tools and pre-existing electronic healthcare data to monitor safety of medical products. The Sentinel Operations Center (SOC) at Harvard Pilgrim Health Care Institute (HPHCI) works closely with FDA and other collaborators to coordinate and/or lead Sentinel System activities. The FDA’s SOC will work with the RELIANCE data coordinating center to link patients aged 65 and older enrolled in the PCORI RELIANCE trial to traditional fee-for-service Medicare data. Linkage of the RELIANCE trial to Medicare data will provide additional information on the primary outcome, all-cause rehospitalization or death, select secondary outcomes such as all-cause healthcare utilization and medication adherence; and will also provide an opportunity to test distributed regression methods with vertically partitioned data. This activity will support FDA’s assessment of the use of real world evidence to help support the approval of new indications for approved drugs which is mandated by the 21st Century Cures Act, as well as build and test infrastructure and methods to conduct pragmatic clinical trials.

7. Where are the package inserts for azithromycin and roflumilast located? (Updated May 2019)

These can be found on the All Sites Overview page (link to this page is also accessible from your site's landing page).

II. Planning Period Activities (Phase 1 IRB)

1. Does my site need to submit a separate IRB application for our University and Hospital? (Updated May 2019)

Many institutions in the RELIANCE network are affiliated with both a University and a Hospital. Most institution’s hospitals and affiliated clinics are covered by the academic institution’s IRB. If you are unsure, please check with your institution’s IRB.

2. Should the Phase 2 protocol be submitted as a separate application from Phase 1? (Updated May 2019)

Yes. Please see the Phase 2 IRB Registration Instructions document on your study page under Phase 2 IRB Materials.

3. Do I need to complete a continuing review application for the Phase 1 protocol? (Updated June 2019)

The University of Illinois at Chicago (Prime) and Johns Hopkins University (DCC) will be keeping the Phase 1 protocol open for continued data analysis and potential publications. We recommend that you check the date of your local expiration and contact your local IRB to ensure you are following your institutions IRB policies when it comes to closing the Phase 1 protocol at your site.

III. Clinical Trial Implementation Period (Phase 2 IRB)

1. What institution is the lead site for the Phase 2 IRB? (Updated May 2019)

The University of Illinois at Chicago is the Prime awardee and the lead site for the Phase 2 IRB. Johns Hopkins University is the data coordinating center for RELIANCE.

2. Can we use our local IRB for Phase 2 of RELIANCE? (Updated May 2019)

Use of SMART IRB is preferred by both the funder, PCORI, and the RELIANCE Executive Committee. If your institution or your PI feel your site should use your local IRB, you may proceed after communicating this to the RELIANCE team by sending an email to reliance.team@reliance-study.org with a cc to your PI.

3. Does my site need to submit a separate IRB application for our University and Hospital? (Updated May 2019)

Many institutions in the RELIANCE network are affiliated with both a University and a Hospital. Most institution’s hospitals and affiliated clinics are covered by the academic institution’s IRB. If you are unsure, please check with your institution’s IRB.

4. What is the electronic data capture (EDC) system that will be used in Phase 2? (Updated May 2019)

DatStat is developing data entry portals for patients, investigators, and call center personnel to be used in Phase 2. The Data Coordinating Center will use a locally developed HIPAA-compliant EDC. For more information please see additional data security information here.

5. How long will RELIANCE keep personal identifiers? (Updated May 2019)

Please see additional data security information here.

6. Will participants be able to opt out of providing their social security number (SSN)
          and health insurance information?
(Updated May 2019)

No, this is required for participation.

7. Will there be additional compensation for sites for changes to the Phase 2 protocol since
          charges may be incurred locally for revision?
(Updated May 2019)

There are no plans to provide additional compensation for amendments.

8. Who at the site will be provided a CHAIRb portal account? (Updated May 2019)

Individuals who are listed in your site's contact database as PI, Co-I, and Coordinator will be automatically provided accounts. You can request additional accounts for personnel at your site by emailing reliance.team@reliance-study.org and cc'ing your site PI.

IV. Site survey

1. How do I submit my site survey data? (Updated May 2019)

Please visit your site’s landing page and scroll to the DATA SUBMISSIONS section to access instructions and your data entry portal. If you have any questions about the data you are submitting, please send an email to reliance.team@reliance-study.org .

2. Can we submit our site survey while our Phase 1 IRB application is pending? (Updated May 2019)

Please wait to submit your data until your initial Phase 1 approval and your Phase 1 Protocol Amendment #1 is approved.

V. Data Audit

1. How does the site survey data generate the audit level data? (Updated May 2019)

Following submission of your site survey data, the Data Coordinating Center will review your submission within 2 business days. If complete they will generate a list of audit IDs. This list will be posted to your site’s landing page within the DATA SUBMISSIONS section and you will be notified via email (please also reference Memo #4 posted in Memos & Calls).

2. Will my site need ongoing access to the EHR for data collection? (Updated May 2019)

A member of your study team will need access to your site’s Electronic Health Record (EHR) to complete the audit of query results. If your audit generates additional questions from the DCC, you may be required to provide additional information. No identifiable information will be requested in Phase 1.

In Phase 2, anyone recruiting or enrolling patients at your institution should have access to the EHR.

3. How will my site receive the data audit selection? (Updated May 2019)

Please reference question V.1. above.

4. We used the ICD-10 codes provided to run our query, should our Investigator review spirometry
          data included in the chart to confirm a diagnosis of COPD?
(Updated May 2019)

No, it is not necessary for your Investigator to review spirometry data to confirm a COPD diagnosis for audit purposes.

5. How do I find out if the patient has a chronic cough with sputum from the medical record? (Updated May 2019)

You will review all available medical records to determine if chronic bronchitis/chronic cough with phlegm or sputum is documented. If you are unsure, ask your Investigator to review the chart, or choose ‘Unable to determine’.

6. How do I determine if the patient’s cough is recurrent for several years? (Updated May 2019)

If the documentation of chronic bronchitis/chronic cough with phlegm or sputum is unclear, choose ‘Unable to determine’.

7. What should I do if there is not a clinical indication for treatment intensification? Should
          I try to determine if a patient would be a good fit for the study?
(Updated May 2019)

Your Investigator should answer Question #18 based on the information available in the electronic health record. We understand it will be difficult to determine definitive eligibility for the study based on review of medical records, this is why RELIANCE is designed to enroll patients during a clinical visit with their Pulmonologist. If you are unsure, choose ‘Unable to determine’.

8. Do I complete the audit if the patient is deceased? (Updated May 2019)

Yes. Please complete the audit for each audit ID assigned. If the patient is deceased, please note this in the comments section.

9. Does the patient qualify if they are homeless? (Updated May 2019)

Homelessness can be transient and is not an exclusion criterion for RELIANCE. Your Investigator should answer Question #18 based on the eligibility criteria and the available documentation in the electronic health record.

10. Can I create a second page for comments and scan that in with my audit form? (Updated May 2019)

Yes.

11. My PI is not a clinician so my Co-I will be the one signing off on the audits, is that ok? (Updated May 2019)

Yes.

12. Is there a medication list for coordinators to use? (Updated May 2019)

There are many brand names and generics for LAMA, LABA, ICS, and combinations. Commonly used medications change from institution to institution. Please consult your Investigator or a clinician on your study team to confirm a list of medications to use for Question #13.

13. Regarding Question #12, what date should I use to determine whether the patient was
            hospitalized over the past 12 months?
(Updated May 2019)

Please use the 12-month period prior to the encounter date that triggered the patient’s inclusion in the query. If the encounter date is not available in your data set, use your query period (e.g. if your query included patient encounters 1/1/2017-12/31/2017, use this 12-month period).

14. Where can I find the list of medications (i.e. list of LAMA, LABA, ICS)? (Updated May 2019)

RELIANCE has not provided a comprehensive list of medications. It was determined that each site should review medication names locally with their site PI/Co-I.