1. Enrollment Logs When, Why, and How-To Use

2. When is an Enrollment Log Needed? All studies for which Consent is obtained require an Enrollment Log. All studies for which Consent is obtained require an Enrollment Log. Why is an Enrollment Log needed? While the Registry captures some subject data, it does not capture all information necessary for Duke IRB continuing reviews or as described in ICH GCP guidelines. Enrollment Logs provide documentation of such information. While the Registry captures some subject data, it does not capture all information necessary for Duke IRB continuing reviews or as described in ICH GCP guidelines. Enrollment Logs provide documentation of such information.

3. Where are Enrollment Logs Found? There are three places to look for an Enrollment Log or template: 1. In a sponsor packet (often in the regulatory binder provided) If an external sponsor provides an enrollment log, you may use it to collect subject data (even if all of the information contained in the CRSO template is not included.) However, you many then have to reconstruct information for continuing review or study completion forms. 2. On the CRSO Webpage The CRSO provides a template for your use that contains the minimum information necessary to collect. You may modify the template to collect additional information, or reorder the information collected. Do not remove any of the fields. 3. Within your SBR Check with your Lead Study Coordinator to see if your SBR has a template enrollment log you may use, provided it includes all of the information captured in the CRSO Enrollment Log.

4. What information is recorded in an Enrollment Log? An Enrollment Log tracks each participant’s study status and demographics necessary for IRB reporting at Duke. The CRSO Enrollment Log template is an Excel spreadsheet containing two tabs – one containing information on participant study status, and the other capturing IRB reporting demographics. The subject-specific information (Name, MRN, and Subject ID#) are auto-populated into the second tab for your convenience.

5. Tab #1: “ENROLLMENT LOG” In this box, enter the Study Title. This cell, too, will be auto-populated for your convenience. In addition, if your study title does not fit the space provided, go to “Format”  “Row”  “AutoFit” and the full title should appear. In this box, enter the IRB# for the study. For your convenience, this information will be auto-populated into the second tab and print on all pages of your enrollment log.

6. Insert subject’s Last Name. Insert subject’s First Name. The first few fields are straightforward… Insert subject’s MRN number.

7. If an external sponsor provides a unique subject identification number, screening number or a randomization number, enter it in the “Subject ID #” column.

8. Enter the date the Person obtaining consent signs the Informed Consent Form. Is there a Screening Period for this study? A drop down box with “Yes” or “No” is provided. Click on the box, and choose a response. If there is a screening period- Is this subject a Screen Failure? A drop down box with “Yes” or “No” is provided. Click on the box, and choose a response.

9. Is there a follow-up period to this study? A drop down box with “Yes” or “No” is provided. Click on the box, and choose a response. The date a subject is discontinued from the study. Or, the end of the treatment period. The date at which follow-up with toxicity-monitoring is complete. The date at which a subject is discontinued from the study. Or, the end of the follow-up period when all data collection is complete.

10. Tab #2 : “Enrollment Demographics” The IRB#, the Study Title, Last Name, First Name, MRN, and Subject ID# is auto-populated into this tab from Tab #1.

11. Male or Female? A drop down box is provided. Click on the box, and choose a response. A drop down box is provided with Duke IRB reporting responses (which follow NIH standards) – Hispanic or Latino; Not Hispanic or Latino; and Unknown. Click on the box, and choose a response. A drop down box is provided with Duke IRB reporting responses (which follow NIH standards) – American Indian / Alaskan Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; White; More than one Race; and, Unknown or Not Reported. Click on the box, and choose a response.

12. Questions? Concerns? For questions or concerns regarding Enrollment Logs, please contact the CRSO at: CRSO.Help@duke.eduOR (919) 681-6650