Page 59 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Study Roles
Study eIRB #
Study Roles
Total # of subjects on Study to Date
Expected Enrollment (Smart form 8.2 in eIRB)
Total Active Patients
Total NEW Enrollment this month
Total subjects screened this month
Last Date of PI Contact
Back Up
This is the number of subjects/records/specimens that are needed to complete the study (beyond screening) at this site as list in eIRB section 8.2. Total Number of Active Patients seen
Coordinator Name: Monthly Report
Due by 12:00 each Friday
These are the roles or activities for which you are responsible. You could have all of the responsibility and would indicate “1-4”, or you might just complete one role or task, such as “Data & Scheduling” and indicate a “3” for this column.
Back-Up
Check the box if you were only the back-up and are not actively engaged in the study.
Total Number of Subjects on Study to Date
This is the total number of informed consent forms or the names of patient’s you have entered on the enrollment log starting when the study received initial approval from the IRB. For example: your study received initial approval from the IRB in 1990 and your records show that you have 611 informed consents. This is the total number of patients that went on that specific protocol. This number will not fluctuate. It is cumulative in nature.
Expected Enrollment
Treatment studies: This is the number of Active patients who either; 1) sign an informed consent, 2) have a visit during the screening phase or 3) are in the treatment phase of the protocol.
Non-Treatment studies: This is the number of patients who sign an informed consent form, or for whom you collect data from for a protocol specified data capture for that month only.
Total NEW Enrollment This Month
This is the total number of patient’s names/identifiers you have entered onto an enrollment log or obtain a signed consent for this month. For example: You identify two (2) patients that meet all Inclusion, and no Exclusion criteria to go on the protocol and obtain their informed consent. You would enter 2 into this box for the month. Data studies will capture the number of study subjects
that are entered onto the enrollment log for this month. This number will fluctuate on a regular basis depending on the population identified from screening.
Total Subjects Screened This Month
This is the total number of patient’s names you have entered onto a screening log for a protocol this month. For example: You look at a clinic schedule and identify 5 potential subjects that may qualify for the study based on the Inclusion/Exclusion criteria. You enter all five (5) of the patients onto your screening log and move forward to identify if they meet the initial Inclusion/Exclusion criteria. This number will fluctuate on a regular basis depending on the potential patient population.
Last Date of PI Contact
This is the last date you had contact with the PI to discuss the status of the study. 2021