Site 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 – Subjects are still being seen
Closed to Enrollment – Subjects are still in follow-up or data collection is continuous
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.
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c. / Number of subjects who have withdrawn or were discontinued from the study: / +
Attach a list of withdrawn/discontinued subjects (subject # only) and reasons for withdrawals/discontinuations.
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: / =
f. / Subjects consented by gender: / Male: / Female:
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)
SECTION4: AUDIT / MONITORING INFORMATION
a. / Has your site been audited / inspected since the approval of this study or last IRB review (Sponsor, FDA, etc.)?
Yes* / No
*provide copies of audit reports or a summary of finding not previously reported.
b. / Is there any new information that would affect the scientific validity of the study?
Yes – provide an explanation. / No
SECTION 5: VULNERABLE SUBJECTS
a. / Did you enroll any subjects from a vulnerable population?
Yes –check all that apply. / No –go to section 6
Children / minors
(NOTE: Age of majority in Alabama and Nebraska - 19; Puerto Rico - 21) / Employees of the PI/site and/or their immediate family members
Pregnant women / fetuses / Students of the PI/site
Economically and/or educationally disadvantaged individuals / Decisionally impaired individuals
Nursing home residents / institutionalized individuals / Prisoners
Limited or non-readers / illiterate individuals / Hearing / visually impaired individuals
Comatose individuals / traumatized individuals
Terminally ill individuals / individuals with life-threatening conditions
Other (specify):
Non-English speaking individuals – complete questions b, c & d
b. / Was an explanation of specific measures used to safeguard these subjects during the recruitment and consent processes previously submitted to the Board?
Yes / No – provide an explanation of specific measures at this time
c. / What was/were the native language(s) of the Non-English speaking subjects enrolled? / N/A
Spanish / Chinese / French / German / Other (specify):
d. / 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.
a. / 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
b. / Did any deviations/violations occur per the above criteria that have not been previously reported?
No Yes – attach all unreported deviations/violations
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. / Changes in subject compensation? / No Yes*
c. / Subject complaints? / No Yes*
d. / Discovery of new information that may affect the subjects’ willingness to continue participation? / No Yes*
e. / Subjects sought compensation for injury? / No Yes*
f. / Discovery of any recent literature relevant to the study? / No Yes*
g. / 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.
Please attach a summary of side effects experienced by study subjects.
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 Sub-investigator(s)? / No Yes*
c. / Change in licensure, board certification or hospital privileges of Principal or Sub-investigator(s)? / No Yes*
d. / Criminal or medical complaints resulting in investigation of Principal or Sub-investigator(s)? / No Yes*
e. / 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: INVESTIGATOR TRAINING
Has the Principal Investigator completed research-related training and/or education in the areas of Good Clinical Practice and Protection of Human Subjects within the past two years? / No Yes
Please provide the following documentation signed and dated within the last two years. If a copy has not been submitted within the last two years it is considered expired. Please make any applicable updates and submit with your report form - ONLY if not current:
  • CV

  • Site Information Form

I acknowledge, as Principal Investigator, that the information provided in response to the above questions is true and accurate.
Principal Investigator Signature / Date

Aspire IRB, LLC

11491 Woodside Avenue

Santee, CA 92071

619.469.0108 (phone)

Version Date: 04/01/2014619.469.4108 (fax)Page 1 of 3