2. PRINCIPAL INVESTIGATOR
First Name, Middle Initial, Last Name, Degree(s); cannot be resident or research fellow
3. ADDRESS AND CONTACT INFORMATION
Institution: Dept/Service: Division/Unit:
Address:
Tel: Fax: Email Address:
Who in your office should be contacted with questions about this study?
Name: Title:
Tel: Fax:Email Address:
4. STUDY TYPE (Check all that apply)
Chart Review Data Repository Diagnostic Gene Transfer
Genetic GWAS Physiologic Human Embryonic Stem Cell
Registry Quality of Life Translational Women’s Health
Efficacy Epidemiologic Observational Pharmacogenomic
Pharmacokinetic QI/QA Safety Survey
Therapeutic Tissue Repository Outcomes (Health Services/Delivery)
Other; specify:
5. STUDY PHASE/DESIGN (Check all that apply)
Pilot Phase I Phase II Phase III Phase IV
Cross-Over Single-Blind Double-Blind Open Label Randomized Placebo-Controlled
Treatment IND Humanitarian Use DeviceSingleCenter Multi-center
6. STUDY SITE LOCATIONS
Indicate below institutions/entities where subjects will be consented and/or where study procedures will be performed by a NSMC investigator(s) (check all that apply):
For guidance, refer to the DHHS document, “Engagement of Institutions in Research:”
NSMC
Outpatient Inpatient
SalemUnion Cancer Center Children’s Hospital
Other; specify:
BWH FH McLean MGH NWH PCHI SRHOther;specify:
Do you plan to subcontract this study to any other sites? Yes No
If yes, explain:
For multi-site research initiated by a NSMC investigator, indicate institutions/entities where subjects will be consented and/or where study procedures will be performed by investigators who are not affiliated with NSMC: or N/A
Note: Investigators who are not affiliated with NSMC must obtain IRB approval from their own institutions. Each non-affiliated performance site must submit documentation of local IRB approval to the NSMC PI prior to initiation of the research. Attach or forward copies of IRB approval to the NSMC IRB when received from the performance site(s).
7. PROJECT ENROLLMENT AND STUDY DURATION
Total enrollment (local sites) #: Total overall enrollment (study-wide) #:
For multi-center studies, is enrollment competitive? Yes No
Accrual information not applicable (registry study, chart review, etc)
Anticipated start date: Anticipated completion date:
8. POTENTIALLY COMPETING STUDIES (EXCLUDING PHASE I)
There are no competing studies for this patient population at the site location(s)
Competing studies exist at the site location(s), specify:
9. EQUIPMENT/SOFTWARE
Will any equipment or software be used or received? Yes No If yes, answer the following:
Describe the equipment/software:
Is the software commercially available? Yes No
Will equipment or software be used to treat patients? Yes No
If equipment will be brought into NSMC, please notify NSMC Clinical Engineering at 978-354-2203
10. DRUG(s)/BIOLOGIC(s) (Attach additional pages if necessary)
Does this study involve the testing of an agent for safety or efficacy or for the study of human physiology?
Yes No (If no, skip to Section 11)
Type of agent: Drug Biologic Dietary Supplement Stable Isotope
Investigational Product Name (Manufacturer’s designation):
Marketed Product Name (Manufacturer Proprietary Trade/Brand Name):
Marketed Product Generic Name:
Manufacturer: Contact at Manufacturer: Telephone #:
Indicate below whether or not the drug/biologic is marketed and when applicable, provide IND information:
Marketed Drug/Biologic (FDA-approved for sale by prescription or over-the-counter)
Marketed indication(s):
Is the drug a Schedule II narcotic? Yes No
Check one below:
The drug/biologic will be used for an indication in the approved labeling
The drug/biologic will be used for a non-approved indication (off-label), specify:
Answer the following questions to determine if an IND is needed:
a) Will data from this study be submitted to the FDA in support of a new indication for use Yes No or to support any other significant change in the labeling for the drug?
b) Will data be used to support a significant change in the advertising for the product? Yes No
c) Will the route of administration or dosage level or use in this subject population significantly Yes No increase the risks (or decrease the acceptability of the risks) associated with the use of
the product?
Note: If the answer to any of the questions above is “Yes,” an IND must be obtained from the FDA.
Not Marketed Drug/Biologic (not FDA approved for sale by prescription or over-the-counter)
Investigational New Drug(IND) Information:IND#: Sponsor of IND:
Who will be responsible for the study agent? NSMC Pharmacy* Other, specify:
If NSMC Pharmacy, indicate whether they will be required to perform any of the following (check all that apply):
Preparation of study drug/biologicRandomization
Storage and/or control of study drug/biologicBlinding (and unblinding if applicable) of study drugs
DispensingOther (specify):
*Approval of Pharmacy Director is required in Section 25
11. DEVICE(S) (Attach additional pages if necessary)
Does this study involve a medical device investigated or used as a comparator, or for non-FDA Yes No
approved medical devices, used as a tool to study human physiology? (If no, skip to Section 12)
Full name of device:
Manufacturer:
Contact at Manufacturer: Telephone #:
Indicate the proposed use of the device: (check one below)
The device will be investigated for safety and effectiveness. (Complete Sections 6-10)
The device will be used as a comparator. (Complete Sections 6, 9, and 10)
The device will be used as a Humanitarian Use Device: HDE#: Sponsor of HDE:
The device will be used as a tool to study human physiology. (Complete below and Section 10)
Is the device commercially available? Yes No
If No, explain:
Briefly describe how the device is being used:
Describe the risks to subjects:
Indicate below whether or not the device is marketed and when applicable, provide IDE information:
Marketed Device, approved by the FDA, check one below:
The device will be investigated for an indication in the FDA-approved labeling.
The device will be investigated for an indication outside the FDA-approved labeling, specify:
Note: Devices being studied off-label for safety and effectiveness are investigational devices.
Not Marketed, not approved by the FDA (investigational device).
IDE#: Sponsor of IDE:
Medicare Reimbursement Category: Category A Device Category B Device
Investigational Devices only: The sponsor considers this medical device study to be (check one below):
A significant risk (SR) device study
A non-significant risk (NSR) device study; answer the following to support the sponsor’s NSR assessment:
a. Is the device intended as an implant and presents a potential for serious risk Yes No
to subject’s health, safety, or welfare?
b.Is the device purported or represented to be for use in supporting or sustaining Yes No
human life and presents a potential for serious risk to the health, safety, or
welfare of a subject?
c. Is the device for a use of substantial importance in diagnosing, curing, mitigating Yes No
or treating disease, or otherwise preventing impairment of human health
and presents a potential for serious risk to subject’s health, safety, or welfare?
d. Does the device otherwise present a potential for serious risk to subject’s health, Yes No
safety, or welfare?
Note:If the answer to any of the questions above is Yes, the device meets the significant risk device criteria at 21 CFR 812.3(m) and requires submission of an IDE application to the FDA.
12. SPONSOR/FUNDING INFORMATION (complete a separate sheet for each sponsor)
Government/Foundation
Government agency/foundation name:
Application type:
Grant/Contract (direct award to NMSC)
Subcontract (from another institution to NSMC), specify institution:
other, explain:
Sponsor Grant # (if known):
Title of proposal (if different):
Principal investigator (if different):
Has the funding been awarded at the time of this submission? Yes No
Note: For HHS-funded research: The NSMC IRB requires investigators to provide a copy of the entire grant application when there is a direct award to NSMC. Salary information (not % effort) may be redacted. Exception: Copies of HHS cooperative group umbrella grants do not need to be submitted.
For NIH-sponsored cooperative group multi-center trials: The NSMC IRB requires a copy of the cooperative group protocol and sample informed consent documents be submitted for review and comparison with the documents submitted for local IRB review. For guidance, refer to, “IRB Review of Applications for HHS Support.”
Corporate (Industry) Agreement
Corporation Name:
Contact at Sponsor :
Name: Tel: Fax: Email:
Sponsor Protocol # (if known):
Who designed the study and will be responsible for the oversight of the trial? Investigator Sponsor
Who holds the Investigational New Drug/Investigational Device Exemption? InvestigatorSponsor NA
Will you share any proprietary or confidential information with the sponsor? Yes No
Do you (Investigator) plan to publish any results from this study? Yes No
If Yes, explain:
Note: When the corporate sponsor designs the study, the corporate sponsor’s protocol must be submitted to the NSMC IRB for review. Before the research can begin, the NSMC IRB must approve the sponsor’s protocol and for studies in which NSMC is engaged in research, the Partners Clinical Research Office(PCRO) must execute the Agreement with the sponsor. Please submit a copy of the proposed Agreement with the application materials to the IRB.
Internal/Institutional Funds or Other Source of Funds
Name of Fund#(s):
Proj/Grant#: %: Proj/Grant#: %:
Other sources of funds, specify:
Do you anticipate that any inventions will be made in the course of the study? Yes No
Is a clinical or academic research organization (CRO/ARO) involved? Yes No
If yes, name:
13.RESEARCH-RELATED COSTS, BILLING AND RESOURCE IMPACT
Expected Principal Investigator percent effort on this study: %
Will the sponsor provide funding (i.e., salary support, study costs, etc.)? Yes No N/A
Will the sponsor provide the device free of charge? Yes No N/A
Will the sponsor cover all subject research-related costs (e.g., drugs, tests)? Yes No N/A
If no to any of above, explain how research-related costs will be covered:
Following shaded questions to be answered for NON-ONCOLOGY studies only:
Will any tests, procedures or interventions performed on subjects be invoiced to a 3rd party payer?
Yes No N/A
If yes, a Medicare Coverage Analysis (MCA) must be completed by the PCRO before NSMC IRB protocol approval.
Does the proposed research study have ANY financial impact to NSMC (e.g., required Yes No N/A
payments for, or purchase of, medical devices, impact on standard reimbursement rates,
impact on standard professional fees, etc)?
If yes, specify and comment on cost per subject, total cost, reimbursement per subject, total reimbursement, etc:
Does the proposed study involve any of the following NSMC resources for research- related Yes No
activities?
NURSING* (check all that apply):
Assessment of physical/mental status of subjects Monitoring requirements – non-invasive and invasive
Additional intravenous requirements Collection of blood and other specimens
Timed laboratory specimen collectionAccompanying patients to test areas
Patient/family education, incl. self and home careAdministration of investigational drugs and other substances
Symptom management/interventionConstant supervision
Requirements from other services that require nursing coordination (please specify services):
Use of new technology/equipment in study protocol (specify):
Estimate time required for research-related activities:
hours per day/per subject X days/subject = total hours per subject
*Approval of Nursing Director(s)is required in Section 25
FACILITIES (check all that apply):
Inpatient rooms Radiology Procedure rooms
Operating rooms Recovery rooms Other (specify):
14. PRIVACY AND CONFIDENTIALITY
Data that include any of the identifiers listed below are considered identifiable health information. For guidance, refer to the PHRC HIPAA Privacy Rule
- Name
- Social security number
- Medical record number
- Address by street location
- Address by town/city/zip code
- Dates (except year), e.g. date of birth; admission/discharge date; date of procedure; date of death
- Telephone number
- Fax number
- Electronic email address
- Web URLs
- Internet protocol (IP) address
- Health plan beneficiary number
- Account number
- Vehicle identification number and serial number, including license plate number
- Certificate/license number
- Medical device identifiers and serial numbers
- Biometric identifiers (finger and voice prints)
- Full face photographic image
- Any other identifier or combination of identifiers likely to identify the subject
Use Of Health/Medical Records (Identifiable Health Information)
Will health/medical records be used to identify and recruit potential subjects? Yes No
Will medical history/clinical information be obtained from the subject’s health/medical record for Yes No
study purposes?
If Yes, describe what information will be abstracted from health/medical records:
Will sensitive personal health information resulting from this study become part of the Yes No
subject’s health/medical record?
Sensitive personal information obtained for research purposes typically does not become part of the subject’s health/medical record. Rather, these data are retained in the research records only.
If Yes, describe what sensitive personal information will become part of the subject’s health/medical records, and explain why this is necessary. Be specific.
Note: Certain categories of medical information are commonly recognized as potentially sensitive, such as information related to mental health; sexual behaviors or sexual orientation; illegal behaviors; and substance abuse. Some genetic test results may be viewed similarly. When applicable, investigators are reminded to inform subjects in the consent form that sensitive personal health information may become part of their health/medical record, e.g., routine testing for HIV infection.
Disclosure of Identifiable Health Information Outside NSMC/Partners
Will identifiable health information be shared with research collaborators outside Partners? Yes No
If Yes, indicate persons or entities outside Partners receiving identifiable health information:
Will identifiable health information be shared with persons or entities outside Partners who are Yes No
notresearch collaborators or part of the research team, but who perform some aspect of
the research on behalf of Partners, e.g., a private recruitment agency, outside laboratory or
data analysis group? Note: In this situation, the persons or entities referred to above are
considered “business associates,” therefore a Business Associate Agreement is required.
If Yes, indicate Business Associate(s):
A Business Associate Agreement has been or will be signed.
Will any other confidential or proprietary information be shared with persons or entities Yes No
outside Partners?
If Yes, indicate persons or entities outside Partners:
15. USE OF SPECIMENS/SAMPLES
Will specimens/samples from a research tissue bank(s) be used in this research study? Yes No
Will permanent or immortal cell lines be developed? Yes No
Will specimens/samples be stored/banked for future use not detailed in this protocol? Yes No
Will specimens/samples collected be sent to research collaborators outside of Partners? Yes No
Will genetic research be done on specimens/samples? Yes No
Note: protocol and consent form must conform to Genetic Guidelines, see the PHRC
“Policies and Guidance Documents” web page
Will investigators be responsible for sending genome-wide association study (GWAS) data to Yes No
the NIH GWAS Data Repository?
Will excess (left-over) specimens/samples collected for clinical care be used in this study? Yes No
If Yes, answer the following:
a. From where will the human material be obtained?
b. Will any of the investigators/research staff perform the procedure that Yes No
provides the excess tissue?
c. Indicate the time period over which the materials were/will be obtained as part of
clinical care: From (month/year): To (month/year):
d. Will you record information about the samples without identifiers or codes? Yes No
e. Do you plan to record health/medical information in order to correlate tissue Yes No
analysis findings with clinical findings?
If No, skip next question (f)
f. Will you be recording any of the identifiers listed in Section 14 with the specimens Yes No
or using a code to link the specimens to any of the identifiers?
If you are recording any identifiers, even if temporarily for QA purposes or to avoid
duplicating records, then answer “Yes”.
If Yes, explain why it would be impossible to conduct the research without access
to and use of identifiable health/medical information.
How will the protected health information (PHI) recorded for the research be
stored and protected?
Will identifiers be removed from the data and destroyed after all of the data Yes No
has been collected, the study has been completed, or all regulatory and sponsor
obligations have been met, consistent with regulatory and institutional research
record keeping requirements?
If No, explain why identifiers must be retained indefinitely, for example, for a
health or research purpose, legal or institutional requirement, or other reason.
Will specimens/samples previously collected for another research purpose be Yes No
used in this study?
If yes, answer the following:
a. From where will the human material be obtained?
b.Will the research be limited to the use of existing samples/data? Yes No
c.Do samples/data retain a code linking sample/data to individual human subjects? Yes No
If Yes, will the key to the code or identity of the subjects ever be known to you? Yes No
If Yes, explain why you need to identify the subjects:
d. Will you be recording any of the identifiers listed in Section 14 with the specimens Yes No
or using a code to link the specimens to any of the identifiers?
If you are recording any identifiers, even if temporarily for QA purposes or to
avoid duplicating records, then answer “Yes”.
If Yes, explain why it would be impossible to conduct the research without access
to and use of identifiable health/medical information.
How will the protected health information (PHI) recorded for the research be
stored and protected?
Will identifiers be removed from the data and destroyed after all of the data Yes No