Site-Specific Protocol Appendix for Industry Sponsored Studies

Tufts Medical Center/Tufts University Health Sciences

Site-Specific Protocol Appendix for Multi-Center or Industry Sponsored Studies

Please complete each field: Do not refer to other documents. This form is to be typed.

IRB #: Principal Investigator:

Study Title:

Site specific appendix version date:

Please describe, in detail, the following items as they occur at this site if they are not already described in the protocol. When describing research team members, please use job titles or roles, not specific names. Please do not list any research team member as a “Co-PI,” only one person may be designated as the PI for a study.

Complete only those sections where the protocol does not detail the activities at this site. Please do not write “see protocol.” It is not adequate that requested information is stated in the informed consent form (ICF) if the requested information is not specifically stated in the protocol. If a section is not applicable, check “N/A” next to the section.

If changes are made to this site-specific appendix, please submit a revised copy to the IRB office. This site-specific protocol appendix must be revised, as applicable, with study amendments and must accompany the protocol each time the protocol is submitted to the IRB.

A. Study Components/Sub-Studies N/A

1.  Are there any study components or sub-studies that are described in the protocol in which Tufts Medical Center/Tufts University Health Sciences subjects will not participate (e.g., pharmacokinetic studies enrolling subjects only at select sites, optional genetic testing, etc.)? Yes No

If yes, list which study components or sub-studies will not have subject participation at this site:

B. Eligibility Criteria N/A

1.  Describe any site-specific eligibility criteria (e.g., if enrollment of minors is permitted per the protocol, but minors will not be enrolled at this site):

2.  Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination):

3.  State who will determine eligibility.

C. Location of Research N/A

1.  Describe the location of the research activities at this site (i.e., where the study interventions, tests, and procedures will occur).

2.  For study activities with significant risk, describe the facilities and equipment for managing emergencies:

D. Record Retention N/A

1.  State where the study records, including ICFs/assent forms, will be retained during the study (state location for original document plus any copies that are made, e.g., ICFs):

2.  State where study records will be retained when the study has been closed (long-term storage):

3.  Describe the security of the location where research data documents, files, reports, etc., will be kept:

4.  State the record retention plan and confirm the plan agrees with Tufts MC / TUHS IRB record retention policies and requirements based on the nature of the study? (e.g., minimum of 7 years unless the study is FDA regulated, in which case records must be kept for 2 years after FDA approval or withdrawal of FDA application; other requirements may exist from sponsor/funding agency.)

E. Drug/Device N/A

1.  Where will the study drug(s) and/or devices be stored:

2.  Describe accountability procedures as they relate to drugs or devices:

3.  Who on the research team, in addition to the Principal Investigator, will be accountable for drugs/devices:

4.  State who will interface with the pharmacy (drugs) or sponsor (devices):

5.  Will pre-printed orders be created to administer study drug? Yes No

a.  If yes, describe the procedures forreviewing and verifying the accuracy ofthe written orders, including who will write them and who will review them:

F. Subject Recruitment N/A

1.  Who will identify potential study subjects:

2.  Describe how subjects will be identified (e.g., medical record screening, approached in clinic):

3.  Who will approach subjects or their legally authorized representative about participation:

4.  When will subjects or their legally authorized representative be approached about participation:

5.  How will subjects or their legally authorized representative be approached about participation:

6.  Is a screening interview/questionnaire or screening script used for recruitment (e.g., when potential subjects respond to recruitment material or an advertisement)? Yes No

If yes, state:

a.  How consent to participate in the screening process will be obtained and documented:

b.  Who will conduct the interview/administer the questionnaire/script:

c.  Who will interpret the data collected from the screening:

d.  The qualifications of the person(s) who will conduct the interviews/administer the questionnaire/script:

e.  How, when, and where the interview or questionnaire or script will be administered:

Attach a copy of all screening interview/questionnaires or screening scripts for this study.

7.  Will a screening log be used (e.g., if you are recording identifiable information when reviewing records, when a potential subject responds to recruitment material or an advertisement)?

Yes No

If yes, please submit the screening log to the IRB.

8.  Will identifying (e.g., name, DOB, medical record #, etc.) screen failure data be retained by the PI or sent to the sponsor (for example on a screening log)? Yes No

If yes, state the plan for retaining data from screen failures that protects privacy and confidentiality.

G. Advertising N/A

Are there any recruitment materials, including internet postings, newspaper, radio, or TV advertisements and/or flyers, for this study? Yes No

1.  If flyers will be used, specify:

a.  Where they will be posted:

b.  From whom permission will be obtained for posting them:

c.  How long they will be posted:

d.  When they will be removed:

2.  If recruitment material is being mailed or otherwise distributed, how will the distribution list be obtained:

3.  For media ads, specify when, where, and how frequently they will be published/aired:

4.  Describe the use of any other recruitment material not specified above:

Please note: When a potential subject responds to recruitment material or an advertisement, if identifiable information will be collected, please submit the telephone screening script and screening log referenced in section F. Subject Recruitment (above).

Please note: All recruitment material must be reviewed and approved by the Tufts MC / TUHS IRB prior to use (except for postings to the Tufts Medical Center On-Line Clinical Trials Listing as long as information in these postings are restricted to the fields listed in the updated form (version date 20 March 2014).

Please attach a copy of all recruitment materials, including advertisements and/or flyers, for this study as well as any permission obtained for posting recruitment material. Please submit untracked, unstamped copy(ies)

H. Transportation N/A

1.  Describe any subject transportation provided for research visits (i.e., provided by the study team or paid for by the research study):

2.  Describe any provisions to ensure safe transport after study interventions that may impair a subject’s ability to travel (eye dilation, sedation, etc):

I. Informed Consent Process N/A

(Refer to Minors section below for additional information related to consenting minor subjects.)

1.  Who will give subjects or their legally authorized representative detailed and comprehensive information about the study:

2.  Where will the consent interview take place (e.g. a private clinic room):

3.  Describe the timing of documenting consent (i.e., how long will subjects be given to consider participation):

4.  Who will obtain written consent:

5.  Specify how the consent process will be structured to ensure independent and thoughtful decision making:

6.  Describe how it will be determined that the subject or their legally authorized representative understands the study:

7.  State the actions that will be taken to avoid coercion and guarantee confidentiality:

8.  Will persons with impaired decision-making capacity be enrolled in the study? Yes No

If yes, specify:

a.  The rationale for the enrollment of persons of impaired decision-making ability. For more information, please refer to the IRB Operations Manual on the IRB website (http://viceprovost.tufts.edu/HSCIRB/).

b.  Who will determine if the subject is able to provide informed consent:

c.  How it will be determined whether the subject is able to provide informed consent:

d.  When it will be determined whether the subject is able to provide informed consent:

e.  Include any other details of the informed consent process not covered above:

f.  If the subject cannot provide informed consent, describe the process for determining the legally authorized representative:

9.  Is it possible or anticipated that non-English speakers will be enrolled in this research study?

Yes No

a.  If no, please provide the ethical and scientific justification for not including non-English speakers.

b.  If yes, state the consent procedures to be followed to enroll non-English speakers (e.g. use of IRB approved Short Forms per the IRB’s Short Form policy). If Short Forms will not be used, be certain to include who will conduct the consent interview, use of interpreters, translated documents, etc.:

Please refer to the IRB Short Form Policy on the IRB website for information on enrolling non-English speakers: http://viceprovost.tufts.edu/HSCIRB/.

J. Site Personnel N/A

1.  Who will be present during study procedure(s):

2.  Specify the proximity of the person(s) above to the subjects while greater than minimal risk procedures are performed:

3.  Who will administer/perform study intervention(s) (e.g., drug dispensing/administration, device implant, tests, procedures, questionnaire administration):

4.  For study activities with significant risk, e.g. study drug infusion, state the qualifications of the member(s) of the research team for managing emergencies:

K. Payment N/A

1.  Will subjects be paid for participation? Yes No

If yes, state:

a.  To whom payment will be made:

b.  The payment schedule:

c.  When payment will be given:

d.  How payment will be made (e.g., cash, check, Clincard):

e.  The payment schedule to be used if a subject withdraws or is withdrawn during the study:

2.  Will subjects be reimbursed for any expenses such as travel, parking, meal, or any other costs? Yes No

If yes, state:

a.  The amount of reimbursement:

b.  When the reimbursement will be given:

c.  How the reimbursement will be made (e.g., cash, check):

d.  How subjects will be informed of the reimbursement, what subjects need to do to obtain reimbursement, and any rules about what they can be reimbursed for, etc. (If a handout with reimbursement instructions will be provided to subjects, please submit it to the IRB for review and approval.)

L. Confidentiality N/A

1.  Identify all parties other than research team members who will have access to the data:

2.  Identify all parties who will have access to the key to the identity code:

3.  Identify all parties who will have access to research records:

4.  Identify part(s) of the study that may place subject confidentiality at risk:

5.  State how any confidentiality risks will be minimized or eliminated:

6.  Describe study procedures to protect subject confidentiality:

7.  State to whom research data, documents, reports, scans, and specimens, etc., will be sent:

a.  Detail what information and/or identifiers will be sent to the parties identified in L1:

b.  Detail how the information will be sent (via e-mail, hand delivered, FedEx, USPS, courier, etc.):

c.  Describe procedures to protect confidentiality of information being sent:

8.  State how data will be:

a.  Recorded:

b.  Coded:

M. Minors N/A

Will minors be enrolled in this study at this site? Yes No

If yes, describe:

1.  Will assent be obtained from the minor? Yes No

If yes, please answer the following:

a.  Will a separate assent form for be used? Yes No

b.  Who will discuss and explain the study to the minor:

c.  When will the discussion or explanation take place:

d.  Where will the discussion or explanation take place (e.g. a private clinic room):

e.  Specify how the assent process will be structured to ensure independent and thoughtful decision making:

f.  How will it be determined that the minor understands the study:

g.  How much time will elapse between introduction of the study and when the subject signs the assent form:

h.  Will minors enrolled in this study reach 18 years of age while in the study? Yes No
Possibly

If yes or “possibly,” describe:

i.  The plan to obtain consent from the subject at age 18 years:

ii.  Who will be responsible for managing the plan:

iii.  Where the consent discussion will take place:

iv.  What will happen if the subject cannot be located to provide consent at age 18 years:

N. Students and/or Employees N/A

1.  Will students and/or employees be specifically targeted or recruited for enrollment into the study? Yes No
If yes:

a.  State the justification for specifically recruiting and enrolling students and/or employees into the study:

b.  Describe how coercion will be eliminated:

c.  State additional protections to ensure the student’s or employee’s confidentiality:

d.  Detail the recruitment methods to be applied to students or employees:

e.  Describe the protections to ensure that a subject’s participation or early withdrawal from the study will not affect his/her status as a student or employee.

Include a letter of support from the responsible administrator from which the students or employees are to be recruited. The letter is to include the responsible administrator’s acknowledgement that they understand the study. It should indicate that they have reviewed the investigator’s responses to items a-f above, concur with their adequacy, and explicitly grant their permission to recruit their students or employees. As the administrator, they share responsibility for ensuring that study involvement does not adversely affect the subject’s role as student or employee; the letter should explicitly acknowledge this shared responsibility. The responsible administrator must be the senior authority for the group being recruited (e.g. residency director for residents, Dean of students, appropriate operations manager or vice president for employees; this person cannot be a study team member).

O. Adverse Event and Unanticipated Problem Reporting

1.  Confirm you will report Adverse Events (AE), internal and external Serious Adverse Event (SAEs) and Unanticipated Problems (UPs) per the Tufts MC / TUHS IRB’s Unanticipated Problem and Adverse Event Reporting policy Yes No

If your AE, SAE, and UP reporting plan for this study differs from the IRB’s policies in any way, please describe:

Please refer to the IRB Unanticipated Problem and Adverse Event Reporting policy on the IRB website for information on reporting AEs/SAEs: http://viceprovost.tufts.edu/HSCIRB/.

P. Other site specific issues N/A

Please describe any other site-specific amendments or details not otherwise included above:

IRB form version: 05/12/14 Page 2 of 7