Frequently Asked Questions

If you cannot find the answer to your question, please contact reliance.team@reliance-study.org
Updated October 2018

I. General

1. What institution is the lead site for the Phase 2 IRB?

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

2. What institution is the data coordinating center for RELIANCE?

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

3. When will PCORI decide on funding for Phase 2?

PCORI will conduct an administrative review of Phase 1 and make a decision regarding the continuation of Phase 2 by December 15, 2018. A full timeline of RELIANCE Milestones and deadlines can be found at the end of this PDF.

4. Where can I find my site's landing page and landing page password?

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.

Remember, your site’s landing page password and your data submission password are different to protect your data. You can access your data submission password using the automated password recovery feature within the Data Submission section on your landing page.

5. Someone new joined our team, how do I make sure they receive RELIANCE trial meeting
          invites and emails?

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.

6. What if my patient is already enrolled in the AIRWISE COPD study?

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.

7. When will we know more about the FDA?

A Task Order is currently being developed, and is expected to be finalized in September 2018. The Executive Committee will review and will incorporate into the current data management plan. The Data Coordinating Center will then revise the Phase 2 protocol to incorporate all relevant material. This will be communicated to sites as soon as possible.

8. Where are the package inserts for azithromycin and roflumilast located?

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

8. What if my site could not get the supplementary survey data submitted in time?

The data coordinating center used the data from the sites that were able to submit by the deadline and incorporated this into summary statistics.

II. Phase 1 IRB

1. Do we need to submit separate IRBs for our University and our Hospital?

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?

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

III. Phase 2 IRB

1. What institution is the lead site for the Phase 2 IRB?

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

2. Can we use our local IRB for Phase 2 of RELIANCE?

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. Do we need to submit separate IRBs for our University and our Hospital?

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. My IRB takes a while to review and register a study; is the June 1 Phase 2 IRB deadline for
          approval or submission?

The June 1 deadline is for Phase 2 protocol and informed consent document submission only. You will update your milestone tracking questions and upload your completed local context survey to indicate your site has completed this milestone.

5. What is the electronic data capture (EDC) system that will be used in Phase 2?

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.

6. Are we allowed to add mandatory site-specific language to the consent document
          in areas other than the highlighted sections?

Yes, you must retain a version of your consent from with tracked changes, as this will be requested for future reference.

7. My IRB suggested adding Phase 2 as a sub-study to Phase 1; should I do this?

No. Phase 2 should not be added to Phase 1 as a sub-study. While Phase 1 was reviewed and approved by your local IRB, most sites will rely on the SMART IRB, CHAIRb, for Phase 2. If you or your IRB have questions, please reach out to reliance.team@reliance-study.org and we will connect you with the CHAIRb point of contact. Please also see the Phase 2 IRB Registration Instructions document on your study page under Phase 2 IRB Materials.

8. Should the Phase 2 protocol be submitted as a separate application from Phase 1?

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

9. How long will RELIANCE keep personal identifiers?

Please see additional data security information here.

10. What about the two places for phone number and website in the consent form that
          are not yet populated?

This website and phone number are in development and will be added in subsequent modifications, prior to launch of the trial.

11. My IRB will only review a protocol for registration once the reviewing SMART IRB has approved my
            local consent form. How do I proceed?

Please reach out to reliance.team@reliance-study.org. We will arrange a teleconference with your IRB and CHAIRb to discuss a path forward.

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

No, this is required for participation.

13. Will there be additional compensation for sites for changes to the Phase 2 protocol since
          charges may be incurred locally for revision?

There are no plans to provide additional compensation for amendments in Phase 1. This will be reviewed with the Executive Committee.

14. What are next steps with IRB?

All sites have submitted the Phase 2 clinical trial protocol and consent template with site-specific language to their IRB for review and request to cede to CHAIRb.

Your IRB personnel should document their intent to cede review review to CHAIRb in the SMART IRB portal. Once your site has done this, an amendment with your consent form is submitted to CHAIRb for review approval. Following CHAIRb-approval, you will receive a stamped consent form along with notification that your site was approved as a clinical center.

15. If my IRB has ceded review, should I mark milestone T as complete?

No. This milestone should not be marked as complete until you have received a stamped consent form and notification that your site has been IRB approved as a participated clinical center.

16. How will we be notified that my site is approved?

Your IRB personnel will be notified through SMART IRB portal, you will also receive notification (addressed to site coordinator and PI/Co-I) via email with a stamped consent form.

17. After we submit our locally-approved consent form to UIC by uploading to our milestone
          tracking survey, what should we do next?

Your consent form will be submitted to CHAIRb (the central IRB used for Phase 2) in an amendment. You will be notified via email when your site is approved as a participating clinical center.

18. What if our IRB does not require an additional notification or protocol registration at our site.

Even if there are no further internal steps at your site, CHAIRb has asked that your site's IRB send an email to chairb@uic.edu to state that the process is complete.

19. Are both the clean and tracked consent forms on the CHAIRb portal?

No, only the clean version of what was submitted by your site will be posted on the CHAIRb portal. You are responsible for keeping the version with tracked changes in your records. If any changes are made during the IRB approval process, these will be provided to you.

20. Who at the site will be provided a CHAIRb portal account?

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?

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?

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?

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 EMR for data collection?

A member of your study team will need access to your site’s Electronic Medical Record (EMR) 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 EMR.

3. How will my site receive the data audit selection?

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?

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?

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?

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?

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?

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?

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?

Yes.

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

Yes.

12. Is there a medication list for coordinators to use?

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?

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).

13. Can we perform the audits if our Phase 1 Amendment #1 is still pending approval?

No. Amendment #1 approval is required prior to submission of the Audit of Query Results.

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

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.