Research Status Report Form
SECTION 1: GENERAL SITE / STUDY INFORMATION / Due date:Sponsor: / Protocol Number:
Protocol Title:
Principal Investigator (PI) Name:
Site Name:
Address:
City: / State: / Zip Code:
Report Type: / Study Continuation – enrollment is still open and subjects are still being seen
Closed to Enrollment –
Research is permanently closed to enrollment; all subjects have completed, but PI is not ready to close-out
Research is permanently closed to enrollment; subjects are in long-term follow-up with no research interventions taking place
Research is permanently closed to enrollment; subjects are still actively participating
Study has not begun – note reason below
Study Cancelled or Terminated / Study is on hold
First subject not yet enrolled / Principal Investigator withdrew
Other (explain):
SECTION 2: CENSUS INFORMATION
All numbers should be cumulative totals, since the study began. Census numbers should not decrease from the last reporting period.
Please be sure to enter a number for a, b, c, d and e and that a+b+c+d=e
a. / Number of subjects still actively participating or being followed in the study:
b. / Number of subjects who have completed the study: / +
c. / Number of subjects who have withdrawn or were discontinued from the study: / +
Please check the reasons for any withdrawals counted above:
Withdrew Consent / Lost to Follow-Up / Didn’t continue to meet Inclusion/Exclusion criteria
Other (explain):
d. / Number of subjects who were screen failures (consented but never randomized / completed a study visit):: / +
e. / 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. / Protocol (version date):
b. / Investigator Brochure (version date): / N/A
c. / IRB-approved Informed Consent Document (approval date):
d. / IRB-approved Child Assent Document (approval date): / N/A
e. / Other IRB-approved Consent Addenda (approval date): / N/A
(e.g. PGX, HIPAA, Pregnancy Partner)
SECTION 4: AUDIT / MONITORING INFORMATION
a. / Has your site been audited / inspected since the approval of this study or last IRB review (Sponsor, FDA, etc.)? / No Yes*
If yes, have you received any documentation related to this audit or inspection? N/A No Yes*
*provide copies of audit reports or a summary of findings not previously reported.
b. / Is there any new information that would affect the scientific validity of the study? / No Yes*
* Please provide an explanation on a separate page.
SECTION 5: VULNERABLE SUBJECTS
a. / Did you pre-screen subjects from a vulnerable population that was not previously approved by Aspire IRB?
Yes – below check all that apply. / No – go to section 6
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 b & c
b. / What was/were the primary language(s) of the Non-English speaking subjects enrolled? / N/A
Spanish / Chinese / French / German / Other (specify):
c. / 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
SECTION 6: UNANTICIPATED EVENTS
Any unanticipated risk or new information that may alter the risk / benefit ratio must be promptly reported to Aspire IRB to ensure the adequate protection of the welfare of the research subjects. This includes deviations/violations that fit the following criteria: unexpected (frequency and severity), increased risk, study related.
Did any events considered to be unexpected and related that may alter the risk / benefit ratio occur for this study that have not been previously reported? No Yes – attach all such unreported events
SECTION 7: STUDY INFORMATION
Have any of the following events occurred that have NOT been previously reported to the IRB?
a. / Release of Data Safety Monitoring Board reports, relevant multi-center trial reports, or other interim findings? / No Yes*
b. / Meeting of Dose Escalation (or equivalent) committees? / N/A No Yes*
c. / Changes in subject compensation? / No Yes*
d. / Subject complaints? / No Yes*
e. / Discovery of new information that may affect the subjects’ willingness to continue participation? / No Yes*
f. / Subjects sought compensation for injury? / No Yes*
g. / Discovery of any recent literature relevant to the study? / No Yes*
h. / Change to the Principal Investigator’s or Sponsor’s risk/benefit ratio assessment based on study results / No Yes*
* Please provide an explanation on a separate page.
SECTION 8: INVESTIGATOR / SUB-INVESTIGATOR STATUS
Have any of the following events occurred that have NOT been previously reported to the IRB?
a. / Change in Principal Investigator? / No Yes*
b. / Change in licensure, board certification or hospital privileges of Principal or Sub-investigator(s)? / No Yes*
c. / Criminal or medical complaints resulting in investigation of Principal or Sub-investigator(s)? / No Yes*
d. / Change in conflicts of interest for the Principal Investigator, Sub-investigator(s) or staff? / No Yes*
* Please provide an explanation on a separate page.
SECTION 9: 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: / @
Name: / Email: / @
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 3 of 3