Form 11 Progress Report

Institutional Review Board at Tallahassee Memorial HealthCare, Inc. Form 11

STUDY PROGRESS REPORT

THIS FORM MUST BE TYPED
HAND WRITTEN FORMS WILL NOT BE ACCEPTED.
Last IRB Approval Date:
Study Expiration Date:
IRB #:
Study Title:
Name of Principal Investigator:
(If a TMH only study, put PI name here OR if a Multi-center Study, put sponsor PI name here & TMH PI name as the Intramural PI.)
Email: / (This could be a university, commercial sponsor, etc.)
Address:
Phone:
Fax:
Name of Intramural Principal Investigator at TMH:
Email: / Address:
Phone:
Fax:
Research Coordinator: / Phone #: Email: Fax:
Detail current funding sources, awards, grants (if applicable):
List other IRBs having jurisdiction over study:
For projects that receive or have submitted application for federal funding, submit one complete copy of the grant/continuation application/NIH Progress Report applicable to this study.
A. / Study Status:
1. Indicate the status of your study by clicking an “X” next to the box next to the appropriate selection below.
Study not yet started.
Open to enrollment/chart review is ongoing.
Closed to enrollment, subjects still receiving treatment or research related interventions.
Closed to enrollment, follow-up and data analysis only. Date Closed to Enrollment:
Attach copies of all study documents still in use. Include copies of the most recent IRB approved consent/assent form(s), including any foreign language consent/assent form(s), surveys, questionnaires, diaries, and all recruitment material, including print and/or all audio advertisements flyers, colleague letters, etc.
2. Please provide: Version & Date Current Consent: Version & Date Current Protocol:
If your protocol or informed consent does not currently indicate a version date, attach a reformatted version of the protocol with the last IRB approval date inserted in the footer.
B. / Subject Enrollment Status
Guidance:
1. Number of subjects enrolled = number of subjects who have signed a consent.
2. For chart reviews, number of subjects enrolled = number of charts that have been reviewed.
1. / Indicate date enrollment began at this site:
2. / Indicate the number of subjects enrolled at this site, during this approval period:
3. / Indicate the total number of subjects that have been enrolled at this site, since this project was initially approved:
Were any of the subjects who have been enrolled minors? Yes No
If Yes, were any of them wards of the state? Yes No
4. / If this a multi-site study, indicate the total number of subjects enrolled study wide (sponsor has this #):
5. / What is the number of subjects you anticipated enrolling atthis site for this protocol?
6. / How many subjects were withdrawn from the study at this siteto-date?
How many subjects were withdrawn from the study at this site during the last approval period?
Describe the circumstances of the subjects withdrawn from the study atthis site during the last approval period (if applicable):
7. / Are signed consent/assent forms for this site, if appropriate, for each subject available for inspection upon request? Yes N/A
If YES: attach copies of the consent/assent forms of the two most recently enrolled study subjects during this approval period. (If you have only enrolled one subject during this approval period, attach a copy of that subject’s signed consent form.)
C. / Investigators/Key Personnel-Collaborating Responsible Investigators
List the names of investigators/key personnel – collaborating responsible investigators on this protocol. Indicate those who are obtaining informed consent from subjects. If Resume/CV indicating the individual’s qualifications to participate in research is not on file, please attach it. N/A = Closed to enrollment.
Obtaining Informed Consent / Name / Evidence of Human Research Protections Education/Experience Attached / Conflict of Interest Attached
IRB Form 3 / Resume/CV Submitted
Previously
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No
Yes No / Yes No / Yes No / Yes No

If additional space is needed, please continue on a separate page.

D. / Conflict of Interest
For guidance click on Conflict of Interest Guidelines. Click here for Disclosure of Conflict of Interest Questionnaire IRB Form3.
Have you or anyone listed on this study had a change in relationship with the study sponsor during this approval period (e.g., consulting, board position, stock ownership opportunities?)
Yes – There has been a change in relationship with the sponsor.
No – There has been no change in relationship with the sponsor.
E. / Protocol Update
Provide a brief narrative of the progress of the study to date. Include any protocol modifications that affect subject participation and safety:
F. / Protocol Consent Modifications
For guidance, click on 8.5 Modifications. Click here for Modification Request form.
Have all protocol/consent modifications been submitted to the IRB? Yes No If not, please submit them at this time.
G. / Protocol Violations
For guidance, click on 8.7 Protocol Violation. Click here for Report of Protocol Violation form.
Have any major protocol violations occurred during this approval period? Yes No
If YES: Have they been reported to the IRB? Yes No
If a major protocol violation has not been reported, you must do so immediately using IRB Form 8c.
Have any minor protocol violations occurred during this approval period? Yes No
If Yes, complete and attach IRB Form 8e: Minor Protocol Deviation Table.
H. / Serious Adverse Events/Unanticipated Problems
For guidance click on, 8.8 Serious Adverse Events/Unanticipated Problems
Click here for forms Report of Serious Internal Adverse Events and Report of Serious External Adverse Events.
Have there been any Reports of Serious Internal Adverse Events (SAEs) during this approval period? Yes No
If YES, have they been reported to the IRB?Yes No
If not, report immediately using a Report of Serious Internal Adverse EventsIRB Form 7a.
How many Internal SAEs occurred during this approval period?
Werethe Internal SAEs reported to the sponsor and/or appropriate agencies? Yes No
If no, report immediately.
ATTACH A BRIEF SUMMARY OF INTERAL ADVERSE EVENTS REPORTED THIS PERIOD.
How many Internal SAEs have occurred since the study started?
How many SAEs have occurred at all sites since the study started (Your monitor has this information)?
Have you had any complaints about how the study is being handledfrom any subjects, i.e., billing, handling insurance, informed consent process, etc.,? Yes No
If YES, describe the situation and any remedial action that was taken:
I. / Data Safety Monitoring Board (DSMB)
Has a DSMB or safety monitoring committee been established for this study? Yes No
If YES, a copy of the most recent DSMB/safety monitoring committee report is:
Attached Unavailable Already submitted – Date submitted:
J. / Relevant Findings/New Information
Has there been any recent study related literature, findings or other relevant information, especially information about risks associated with this research? Yes No If YES, provide a brief summary including a justification for continuation of thestudy.
K. / EXPEDITED VS FULL BOARD REVIEW

Determine if the research qualifies for Expedited Review. Read all sections before making a final determination. “Stop” indicates Full Board Review is necessary. Research qualifying for expedited review may require written informed consent. Inclusion on this list merely means that the activity may be eligible for review through the expedited review procedure. However, when the specific circumstances of the proposed research are considered, it may be determined that a higher level of review is necessary. Check the relevant boxes. Research may qualify for expedited review if it:

a)Involves no more than minimal risk. The probability and magnitude of harm or discomfort Yes No-Stop

anticipated in the proposed research are not greater, in and of themselves, than those ordinarily

encountered in daily life or during the performance of routine physical or psychological

examinations or tests.

b)Does this research project include abortuses, children (18 years of age), decisionally impaired

persons, educationally/economically disadvantaged, TMH employees, fetuses, human in vitro

fertilization, institutionalized persons,pregnant women, prisoners, students, neonates, or any

population that would be considered vulnerable?Yes-Stop No

c)Is it anticipated that any part of your research project will present more than the probability

and magnitude of harm or discomfort is greater in and of itself than any ordinarily encountered

in daily life or during the performance of routine physical or psychological examinations or tests?Yes-Stop No

d)Could identification of the subjects and/or their responses reasonably place them at risk of

criminal or civil liability or be damaging to the subjects’ financial standing, employability,

insurability, reputation, or be stigmatizing? Yes-Stop No

e)Will reasonable and appropriate protections be implemented so that risks related to invasion

confidentiality is no of privacy and breach of greater than minimal? Yes No-Stop

f)Does your research project involve classified human subjects research? Yes-Stop No

g)All of the human subject research in your project falls into one or more of the following

expedited review categories?

(Check all that apply from the following list describing the eligible categories.)Yes No-Stop

Category 1

This category encompasses some clinical studies of drugs and medical devices (investigational new drugs or investigational new devices/equipment).

Is an investigational new drug application (21 CFR Part 312) required to conduct

this study?Yes-Stop No

Does the research on the marketed drug significantly increase the risks or decrease

the acceptability of the risks associated with the use of the product?Yes-Stop No

Is it anticipated that any part of your research project will present more than the

probability and magnitude of harm or discomfort is greater in and of itself than

any ordinarily encountered in daily life or during the performance of routine physical

or psychological examinations or tests?Yes-Stop No

Is an investigational device exemption application (21 CFR Part 812) required to

conduct this study?Yes-Stop No

Is the medical device cleared/approved for marketing and being used in accordance

with its cleared/approved labeling in this study?Yes No-Stop

Category 2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

From healthy, non-pregnant adults who weigh at least 110 pounds. For these subject, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
From other adults and children, considering the age, weight, and health of the subjects, thecollection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml perkg in an 8 week period and collection must not occur more frequently than 2 times per week.

Category 3

Prospective collection of biological specimens for research purposes by non-invasive means. (Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions [including sweat]; (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (I) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washing; (j) sputum collected after saline mist nebulization).

Category 4

Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed by clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) (Examples: (a) physical sensors that are applied whether to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalogy, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual).

Category 5

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

Category 6

Collection of data from voice, video, digital or image recordings made for research purposes.

Category 7

Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Category 8

Continuing review of research previously approved by the convened IRB as follows:

Is the research permanently closed to the enrollment of new subjects?Yes No-Stop
Have all subjects completed all research-related interventions?Yes No-Stop
The research remaining does not involve any further treatment or intervention.

Theresearch remaining active only for long-term follow-up of subjects?Yes No-Stop

No subjects were enrolled and no additional risks have been identified?Yes No-Stop
Is the remaining research activities are limited to data analysis?Yes No-Stop

Continuing review of research, not conducted under an investigational new drug

application or investigational device exemption where categories two (2) through

eight (8) do not apply but the IRB has determined and documented at a convened

meeting that the research involves no greater than minimal risk and no additional

risks have been identified.Yes No-Stop

Statement of Compliance
If the Institutional Review Board approves continuation of this project, I agree to:
Execute the research plan as described in this application, including obtaining informed consent from all subjects as deemed appropriate by the IRB.
Report to the IRB any research changes in the plan which may affect the use of human subjects, prior to its implementation.
Report all unexpectedserious adverse events within 1 weekof occurrence or knowledge of event by the investigator.
Report within 3-5 business days of occurrence or notification by sponsor any problems, which arise in connection with human subjects including any external serious and adverse events.
Report progress to the IRB, as required, at least annually.
Report to sponsors and agencies as required.
Notify the IRB when the study is terminated.
Maintain records of the research, including consent documents, for a minimum of three years beyond the termination of the study or longer as specified by the funding agency or sponsor of the project.
Submit all recruitment materials, publications, notification of changes in key personnelto the IRB approval prior to use.
Apply and comply with all Federal, State, Institutional regulations, the Belmont Report Ethical Principals, Good Clinical Practice Guidelines (ICH), Helsinki Declaration and IRB Guidelines governing this research.
Cooperate with the IRB.

There will be random audits of research protocols by the Office of Research/IRB.

Failure to comply with any of the above regulations may result in CLOSURE OF THE STUDY by the IRB.

By signing below, I affirm that I am the Intramural Principal Investigator PrincipalInvestigator

(Check Appropriate Box)

and request approval forcontinuation of this project. I hereby assure compliance to the above and assume responsibility for all activities, investigators and key personnel involved in this project.

______

Date Signature of Principal/Intramural Principal Investigator Title

ForOffice of Research/IRB USE ONLY

Expedited Study Progress Report Reviewer’s Comments:

Expedited Approval for Continuation of Renewal – agree with criteria described above.

Expedited Approval for Continuation of Renewal – using Category ______.

Comments:______

I certify that I have reviewed all documentation for this study. It is approved for continuation using expedited review guidelines. The approval expires ______one year from the approval date.

______

IRB Chair or DesigneeDate

Not Approved for Expedited Review – Project requires Full Board review ofcontinuation the study Progress Report. Please submit the Study Progress Report (IRB Form 11) to receive Full Board review.