Establishing a Registry Account

This page provides instructions for establishing and activating a Registry account, as well as getting started on data entry. The USCLC Registry uses the Answers Ahead platform. You can view the Answers Ahead information flyer here.

How to Establish Your Account

1. Inform Duke at either USCLC-Duke@Duke.edu or the Registry Chairman, Dr. Elise Olsen (Elise.olsen@duke.edu) that your site is interested in becoming a Registry member. You will be directed to the documents you will need to complete prior to being given access to the Registry for data entry, and a Duke box (an online document repository for your account) will be set up for you to upload administrative forms.

2. Complete the following administrative forms and upload to your Duke box:

a. Your site’s Institutional Review Board (IRB) approval of the Registry protocol and Informed Consent Form (ICF) [Where do they obtain this?],

b. the USCLC Registry Site Agreement (at this link), and/

c. the Answers Ahead End User License Agreement (EULA) (at this link), signed by your institution’s legal team.

Once these documents have been uploaded, Duke will notify Answers Ahead and will let [IMCOMPLETE SENTENCE].

Answers Ahead will then reach out to the Principal Investigator (PI), who will be sent an email with the subject line Answers Ahead Account Activation – USCLC. The email will provide important access information, most notably a temporary password and a link to activate the institution’s account.

IMPORTANT: The PI and any Co-Investigators must be members in good standing of the USCLC in order to enter data. If necessary, establish or renew your membership here, or contact Kathleen Caillouette, USCLC administrator (kathleen@tnmed.org), with any questions.

3. The PI must then inform Jeff Schwartz at Answers Ahead by email (jeff@answersahead.com) of the designated user(s) who will have access to the Registry to enter data. That information should also be uploaded into your site’s Duke box. Designated users will then be sent an email with the subject line Answers Ahead Account Activation – USCLC. The email will provide important information on access, most notably a temporary password and a link< to activate the user’s account.

If there is another physician at your site who is IRB-approved as a Co-Investigator for the study and wishes to enter patient data separately vs. under the PI, please contact the Dr. Olsen (elise.olsen@duke.edu). As noted above, all Co-Investigators must be members in good standing of the USCLC.

How to Activate Your Account

1. You will receive an Open a web browser and navigate to the link in the email: https://www.answersahead.io/auth/verify?tenant=usclc

2. Scroll to the bottom of the EULA and click the checkbox next to the statement I agree to the Terms and Conditions. This will take you to a page titled Setup Account Password.

3. Enter you email address

4. Enter the temporary password

5. Enter your new password

6. Re-enter your new password (see image on next page)

7. Click the Next button. There should be a message that says Password updated

8. You may now login

a. The Registry is always usclc – all lowercase

b. Enter your email address – all lowercase

9. Once logged in you will see the Subject List (see below)

Consenting Subjects

You may consent the patient in person or online. Please note that the following are needed for a fully executed ICF:

1. Use of proper, current consent version. Any renewal of IRB approval of the protocol will likely update the version of the consent form to use. Please check that your consent form is the most updated and approved version.

2. All expected signatures, dates, and, if pertinent at your site, times are filled out fully at the end of the consent.

3. Subject initials should be signed in the lower right corner of all pages except for final page.

4. Please double check that all components of the consent form have been signed and dated appropriately before the patient leaves the clinic. If there are omissions or errors, the patient will have to sign a new consent form at the next visit, and further data cannot be entered in the Registry until that is completed.

Generating a Unique Study Number

When you have completed consenting a patient, you should log in to Answers Ahead.

1. Open the login page: https://www.answersahead.io/auth/login?tenant=usclc

2. Enter usclc as the registry, followed by your email (all lowercase) as the username. Enter the password you created and click the Login button.

3. A successful login will bring you to the Subject List (see below) which includes all of patients associated with your site.

4. Click the New button.

• You will be brought to the Consent Data page

• Click the Yes to indicate that the subject has been consented.

• Enter the date the subject was consented.

• Enter the name of the person entering thedata.

• Your institution and physician should already be selected.

• Press the Generate button to create the USCLC Registry number

• Click the Save and Next button.

• At this point, you can elect to log out and enter data later or continue to add data. Regardless of whether you continue to add data at this point, you will need to do the following with the subject’s ICF.

Finalization of Consent Form Documentation

1. Please add the unique USCLC Registry Study Number to the upper right corner of the patient’s fully executed ICF.

2. Scan and save the ICF (with the Study Number added) with the electronic title of “Consent-Unique Number- Date”

Example: Consent- 0001-01-00003- 30Aug22.pdf

• Upload the ICF (with Unique Study Number added) to the secure USCLC Registry Box folder that each site has been individually assigned.

• Once the ICF has been received in the USCLC Registry Box, it will be reviewed within 10 business days to ensure correct consent version and for completeness.

– If there are no issues, a key will be made of subject name and DOB, site, physician, date of consent, and USCLC Registry number. The consent form will then be destroyed and Answers Ahead and site will be informed that local data is now able to be moved to aggregate USCLC data and further data may be entered on this patient. The site should keep a fully executed version of the ICF with the study number at their site.

– If there are problems with the consent form, the USCLC Central Site will notify the site via email within 10 days of issues with the ICF, your site will be asked to correct the issue(s), and resubmit the ICF to the USCLC Registry Box. The site has 4 weeks in which to insure that there is a fully authorized and approved ICF for any individual patient whose data is to be entered into the Registry. Once the ICF has been approved as fully authorized, a key will be made of subject name and DOB, site, physician, date of consent, and USCLC Registry number. The consent form will then be destroyed and Answers Ahead and site will be informed that local data is now able to be moved to aggregate USCLC data and further data may be entered on this patient. The site should keep a fully executed version of the ICF with the study number at their site.

Registry Support

Registry support is provided by email (support@answersahead.com) from 9am – 5pm EST, Monday – Friday.

Contact Information

For questions related to Regulatory issues or ICF review and approval by USCLC Central Site, please contact usclc-duke@duke.edu.

For general questions related to Answers Ahead, please contact Jeff Schwartz (jeff@answersahead.com) or 773-771-5333.

For questions about your USCLC membership, please contact Kathleen Caillouette (kathleen@tnmed.org).

For general questions related to the protocol or if you are not receiving the necessary answers to your questions from the above contacts, please contact Dr. Elise Olsen (elise.olsen@duke.edu).

Login information

Login URL: https://www.answersahead.io/auth/login?tenant=usclc
Registry: usclc
Username: Email address (lowercase)
Password: Your account password

Forgot Password / Password Reset

1. Click I forgot my password from the Login URL above or click this link
2. Registry: usclc
3. Username: Email address (lowercase)