Below are PDFs of the materials presented during past coordinator calls. Click on the link to download or view the PDFs.
April 4 & 5, 2018
Steering Committee Calls
Below are PDFs of the materials presented during past steering committee calls. Click on the link to download or view the PDFs.
April 24, 2018
Frequently Asked Questions
If you cannot find the answer to your question, please contact firstname.lastname@example.org
1. When is the PCORI review of the Phase I data and decision on Phase II?
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.
2. 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 email@example.com.
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.
3. 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.
1. Can we use our local IRB for Phase II 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 firstname.lastname@example.org with a cc to your PI.
2. 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.
III. 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 email@example.com .
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.
IV. 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 IV.1. above.