Pre-Screening Plan Status Report Form

Pre-Screening Plan Status Report Form

► HANDWRITTEN FORMS WILL NOT BE ACCEPTED ◄

SECTION 1: GENERAL PRE-SCREENING INFORMATION / Due date:
Responsible Party or
Principal Investigator (PI) Name:
Site Name:
Report Type: / Pre-screening Plan Continuation –Subjectsare still being screened
Final/Pre-screening Completed – Screening Consent Document no longer being used
Screening has not begun / first prospective subject not screened yet
SECTION 2: CENSUS INFORMATION
Census numbers should not decrease from the last reporting period.
TOTAL NUMBER OF SUBJECTS WHO HAVE BEEN CONSENTED FOR THIS STUDY: / =
SECTION 3: STUDY DOCUMENTS
Please provide the Board with the version / approval dates of all documents currently being used by the site for this study.
a. / Pre-Screening Plan / Protocol (version date):
b. / IRB-approved Informed Consent Document (approval date):
c. / IRB-approved Child Assent Document (approval date): / N/A
SECTION 4: PRE-SCREENING EVENTS
Have any of the following events occurred that have NOT been previously reported to the IRB?
a. / Changes in subject compensation? / No Yes*
b. / Subject complaints? / No Yes*
c. / Did any events considered to be unexpected and relatedto the pre-screening procedures that may have increased the risk of harm to the subjects occur? / No Yes*
d. / Subjects sought compensation for injury? / No Yes*
e. / Have there been any additional procedures performed that were not previously approved by Aspire IRB? / No Yes*
f. / Did you pre-screen subjects from a vulnerable population that was not previously approved by Aspire IRB?
Yes –check all that apply. / No –go to section 5
Children / minors
(NOTE: Age of majority in Alabama and Nebraska - 19; Puerto Rico - 21) / Adults with diminished decision-making capacity
Pregnant women / fetuses / Educationally Disadvantaged
Economically disadvantaged individuals / Visually impaired or illiterate
Employees/Colleagues/Students of the Principal Investigator and/or Study Staff
Terminally ill individuals / individuals with life-threatening conditions
Other (specify):
Non-English speaking individuals – complete questions g & h
g. / What was/were the primary language(s) of the Non-English speaking subjects enrolled? / N/A
Spanish / Chinese / French / German / Other (specify):
h. / Were non-English speaking subjects provided IRB-approved consent forms in their native language(s)? / N/A
Yes / *No – provide an explanation of the consent process that was used
* Please provide an explanation on a separate page.
SECTION 5: SITE CONTACT CONFIRMATION
Has the primary contact person responsible for communicating to the IRB changed since the last reporting period? / No *Yes
*If yes, please provide the most current contact information below:
Study Site Contact* / Email: / @
Phone: / FAX:
Are there any new individuals who may need access to the web portal (attach additional sheet if necessary)
Name: / Email: / @
The person completing this form attests to the information provided as being true and accurate and that this information is being submitted on behalf of the Principal Investigator.
Form Completed by:
Name (Printed) / Date
@
Telephone Number / E-mail

Before you submit…

Please provide the IRB with a current copy of the P.I.’s CV (signed and dated within the last two years) as well as a copy of the P.I.’s current medical license when submitting this report form.
If you were required to submit a Site Information Form at the time of initial review, please ensure the Site Information Forms on file with the IRB for this P.I. are current within the last two years. If they are not, please use this time to re-submit them.

Aspire IRB, Inc.

11491 Woodside Avenue

Santee, CA 92071

619.469.0108 (phone)

Version Date:January 26, 2018 619.469.4108 (fax)Page 1 of 2