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New Study Submission Application
The New Study Submission Applicationis completed to initiate the review process for a new research study. This form should be completed by the Sponsor/CRO or by Sites/Institutions serving as the study’s primary point of contact for Sterling IRB (i.e. sites/institutions conducting an Investigator Initiated study or those submitting a study on behalf of the Sponsor/CRO).
PROTOCOL INFORMATION
Sponsor: / CRO:Protocol No.: / Sites that will be submitted to SIRB are located in: U.S. Canada*
# of U.S. sites: # of CAN sites:
For studies involving more than one Principal Investigator:
Sites will submit initial PI/site submission application directly to Sterling IRB
OR
*The Sponsor/CRO will submit initial PI/site submission applications on behalf
of the site
*Note: any initial submission application received directly from the site will be held pending Sponsor/CRO approval
Protocol Title:
Expected duration of this study (from date of enrollment of first subject to study close-out):
Is this an investigator-initiated study? Yes No
An investigator-initiated study involves an individual who both initiates and conducts the study. Investigator-initiated studies
generally do not involve any entity other than this individual. This individual assumes the responsibilities of, and must comply
with, the regulations that are applicable to both a sponsor and an investigator. (If you have any questions regarding whether your study should be considered investigator-initiated, please contact our Client Services department at 1-888-636-1062 or )
PRIMARY CONTACTINFORMATION
Primary contact for Sterling IRB: Sponsor CRO Investigator (Site/Institution) OtherPrimary Contact Person:
Street Address: / City: State: Zip: Country:
Phone/Ext:
Email Address:
Company and Position:
Additional Contact Person: / Email Address:
Phone/Ext: / Company and Position:
Notify when IRB issued documents are available in SilverLink?: Yes No
Additional Contact Person: / Email Address:
Phone/Ext: / Company and Position:
Notify when IRB issued documents are available in SilverLink?: Yes No
DOCUMENT DISTRIBUTION INFORMATION
Designated contacts listed above will be provided with access to this study in SilverLink, Sterling’s secure web portal. Contacts may also be notified when Sterling IRB uploads documents related to the study and study sites to SilverLink. You may select notification preferences from the options listed in the sections above.Submission and acknowledgement of study-wide safety (IND safety reports)information:
Sponsor/CRO will submit safety information to Sterling IRB and Sterling IRB will provide an acknowledgement to each site
Sponsor/CRO will submit safety information to Sterling IRB and Sterling IRB will provide an acknowledgement to
Sponsor/CRO only (Sponsor/CRO will be responsible for distributing acknowledgement letter to sites as necessary)
N/A (study is investigator-initiated or will not require the submission of safety information)
BILLING INFORMATION
Company: / Attention:Street Address: / City: State: Zip: Country:
Phone/Ext:
PO number: / Special Instructions:
How do you wish to receive invoices?
Email US Mail (to the billing address) / Email Address:
FUNDING INFORMATION
The source of funding for this research study will be (check all that apply):
Drug/Biologic or Medical Device Company
*Federal Government
If so, *please complete the Federally Funded Studies section below
Other (Please describe):
FEDERALLY OR PUBLICALLY FUNDED STUDIES*
N/A (Skip to Next Section)
1.Please identify the federal or publicdepartment/agency(ies) funding or supporting this research:*Note: If the research is supportedor conducted by the Department of Defense, a completed Department of Defense Supplement Form located on our website at under “Forms” must be included with your submission.
2.Will you be submitting a copy of the grant application and/or contract supporting this research submission? Yes *No
*If no, please indicate the reason why a grant application and/or contract is unavailable:
Submitting party is not the awardee institution (i.e. a non-awardee site or subcontractor)
Award is a multi-project award that is not specific to this research and the proposal did not contain definite plans for
human subjects research (e.g., a program project or center grant)
Submission is a Cooperative Oncology Group research study (e.g., ECOG, SWOG, etc.)
Other (Please describe):
*Note:A complete copy of the grant application and/or federal contract or rationale why this documentation is unavailable must be provided with this submission.
3.Will you ensure that each site participating in this study is aware that the research must be conducted under a Federalwide
Assurance (FWA)? Yes *No
*If No, please provide an explanation:
*Note: An Authorization Agreement, IRB Jurisdiction Form (for SMART IRB participating sites), or Institution Cover Page (for sites that maintain a MSA with Sterling) is required from each site. These forms are located on our website at in the “forms for institutions” section.
SPECIFIC PROTOCOL INFORMATION
4a.If your research is minimal riskand appears in the Federal Register’s categories of research that may receive expedited IRB review, would you like for Sterling IRB to evaluate your research submission through an expedited review process? *Yes No*Note: A completed Sterling IRB Expedited Review Request located on our website at under “Forms” must be included with your submission. Sterling IRB may employ the expedited review procedure for research involving no more than minimal risk and appearing in the Federal Register’s categories of research that may receive expedited IRB review. Sterling IRB does not review research involving prisoners as research subjects via the expedited review procedure.
This study involves/investigates (check all that apply):
Drug/Biologic Tissue/Blood Bank (skip to #13)
Device Retrospective Chart Review (skip to #13)
Diagnostic Testing Facility Registry/Observational Study (skip to #13)
Health Economics and Outcomes Research
Software Social Science/Behavioral Study (skip to #11)
Food & Beverage/Dietary Supplement Other (Please describe):
5. Does this study involve an Investigational Device? *Yes No
*If yes, please attach one of the following types of documentation:
FDA Investigational Device Exemption (IDE) Letter verifying the IDE number for the proposed use (if this is not provided,
a protocol from the Sponsor imprinted with the IDE number for the proposed use must be submitted),
Letter from Sponsor assessing how/why the device is a non-significant risk (NSR) device,
Letter from Sponsor explaining why the device study is exempt from IDE requirements pursuant to 21 CFR 812.2(c), OR
Check here if this device is a combination product and is being regulated by the FDA under an Investigational New Drug
(IND) application
6a. Does this study involve the investigational use of a drug/biologic or investigational use of a marketed drug/biologic?
*Yes No
*If yes, please identify the IND application status for this study:
IND is active and research may commence upon IRB approval*
IND Number:
IND application received by FDA less than 30 days ago*
date of submittal:
IND application has not been submitted*
expected date of submittal:
An IND is not required for the following reasons:
*Note:Approval documents will not be processed for US sites until Sterling IRB is in receipt of an IND number. In accordance with the regulations set forth at 21CFR312.40, an investigator may not administer an investigational new drug to human subjects until the IND goes into effect.
For studies involving Canadian sites:
*If yes, please identify the CTA application status for this study:
No objection letter received or no objection has been raised by Health Canada within 30 daysof the CTA*
CTA Control Number:
CTA relating to this study received by Health Canada less than 30 days ago*
date of submittal:
CTA relating to this study has not been submitted*
expected date of submittal:
A CTA is not required for the following reasons:
*Note: Approval documents will not be processed for Canadian sites until Sterling IRB is in receipt of a copy of the No Objection Letteror written confirmation that the CTA is active.
6b. Does this submission include any external adverse event reports (“IND Safety Reports”)? *Yes No
*If yes, please provide the safety reporting cut-off date:
*Note:Please provide any external adverse event reports that are after the safety reporting cut-off date and that may, in the opinion of the Sponsor/CRO, represent an unanticipated problem involving risks to subjects or others. Any reports that are prior to the safety reporting cut-off date will not be acknowledged or reviewed.
7. What phase of research classifies the current study? (please confirm with Sponsor prior to submission)
Phase I Phase II Phase III Phase IV N/A
8. Is this an FDA-approved study article? *Yes No
*If yes, list the indications for which it is approved:
For studies involving Canadian sites:
Is this a Health Canada-approved study article? *Yes No
*If yes, list the indications for which it is approved:
9. Does this research involve a controlled substance or does it involve the treatment of drug abuse *Yes No
using any drug (scheduled or not)?
*If yes, please answer the questions below:
The controlled substance is:
Schedule I Schedule II Schedule III Schedule IV Schedule V
For studies involving US sites:
Will you advise each US site participating in this study to provideSterling IRB with a copy of the DEA registration
or controlled substance license for each investigator prescribing and/or dispensing the controlled substance?
Yes *No *If No, please explain:
If the study will be conducted in California and involves a Schedule I or Schedule II controlled substance, will you ensure that
the study is submitted to the Research Advisory Panel of California (RAPC) for review and approval prior to the initiation of the
research? Yes No N/A
For studies involving Canadian sites:
Will you advise each Canadian site participating in this study to provide Sterling IRB with a copy of the Letter of Exemption
under the Controlled Drugs and Substances Act and Regulations, and Letter of Authorization permitting the controlled
substance to be shipped to the Qualified Investigator.
Yes *No *If No, please explain:
*Note:If the study involves a Schedule I or Schedule II controlled substance or the treatment of drug abuse using any drug, additional state laws may apply.
10. Does the study contain a placebo arm? *Yes No
*If yes, provide a statement of justification:
11. Please describe the provisions that have been made to compensate subjects for study-related injury:
12. Will you ensure that each site has adequate resources (e.g. emergency equipment, personnel) to protect
research subjects and to conduct the study in accordance with the protocol? Yes *No
*If No, please provide an explanation:
12a. Please indicate the equipment/personnel that will be required at each site to treat medical emergencies, should they occur:
(Check all that are applicable)
CPR certified personnel/staff (AHA, Red Cross or comparable certification)
ACLS trained personnel and Crash Cart
Emergency drugs and supplies to stabilize subjects until emergency personnel arrive
On-site paramedics / Emergency response team within facility Other (please list):
13. If incidental findings are discovered during the course of the research,will you ensure that the Yes *No
investigator submits a plan to Sterling IRB indicating how they will disclose such findings to participants?
*If No, please provide an explanation:
14.What are the study’s provisions for data and safety monitoring?*
Data Safety Monitoring Board (“DSMB”), Data Monitoring Committee (“DMC”), Data Safety Committee (“DSC”) or other
formal monitoring body+
Other (description required):
*Urgent data and safety monitoring reports (e.g. reports indicating an unanticipated problem involving risk) must be reported to the IRB within 10 business days of the Sponsor/CROs’ receipt of the report; routine reports may be submitted with the Sponsor Continuing Review Status Report
+If available, please include the DSMB charter with your submission.
15a. Will this study enroll participants from any of the following vulnerable populations? *Yes No
*If yes, please check all that apply:
Children or Minors Pregnant Women or Fetuses
Prisoners Mentally Disabled/Cognitively Impaired
15b. Is enrollment of the following vulnerable populations allowed? *Yes No
* If yes, please check all that apply:
Employees (or family members of employees) of the PI/site*
Employees (or family members of employees) of the Sponsor*
Limited or non-readers (e.g., blind, illiterate)*
If enrollment of these vulnerable populations varies from the options above, please describe*:
*Additional language will be included in the informed consent addressing these populations.
16. Will women and/or minorities be excluded from this research study? *Yes No
* If yes, please provide a justification for this/these exclusion(s):
17. Does the study include a sub-study? *Yes No
* If yes, is the sub-study being submitted at this time? Yes No
* If yes, please list all sub-studies:
* If yes, the list of sites participating in each sub-study is: Attached To be determined All sites are participating
18. If this study involves Canadian sites, is trial registration required for this study? Yes No N/A
If yes, please identify the trial registration status for this study:
Trial registration is active
Trial Registration Number:
Name of the Registry:
Trial registration is not yet active*
expected date of registration:
If no, please explain:
*Approval documents will not be processed for Canadian sites until Sterling IRB receives written confirmation of the trial registration number and the name of the registry in which the trial is registered. For additional information, please see TCPS Article 11.3
19a. Has this protocol previously been disapproved or had approval terminated by another IRB? *Yes No
* If yes, please attach a detailed explanation of the previous IRB’s decisions.
19b. Is this protocol under review by another IRB? *Yes No
* If yes, are you requesting transfer of IRB oversight? **Yes No
**If yes, please provide a brief explanation of the reason for this request:
**Note: The Transfer of IRB Oversight Submission Checklist for the Sponsor and additional attachments solicited therein must accompany this submission.
20. Does this study involve genetic testing? Yes No
Does this study involve recombinant or synthetic DNA (i.e. human gene transfer)? Yes No
21. Will the Sponsor/CRO verify that each investigator has the appropriate education, training and Yes *No
experience to assume responsibility for the conduct of the trial?
* If No, please provide an explanation:
INFORMED CONSENT INFORMATION
22. Are you requesting a Waiver or Alteration of Informed Consent or a Waiver of Documentation of Informed Consent for thissubmission? *Yes No
* If yes, please indicate the type of consent waiver you are requesting:
Waiver or Alteration of Informed Consent(skip to #27)
Waiver of Documentation of Informed Consent(skip to #25)
*Note:Consent waiver request forms are located on our website at under “Forms.”
23. Does the protocol allow for use of Legally Authorized Representatives (LARs) for adultsin this study with diminished decision-
making capacity? *Yes No
Note: a parent/legal guardian of a minor acting as LAR for that minor is addressed separately
* If yes, please provide justification for use of an LAR for adult subjects in this study:
24.Would you like for Sterling IRB to write the consent document(s) for you? *Yes No
* Please provide any additional information regarding this request here:
*Note: Sterling IRB offers specialized informed consent/parental permission and assent document preparation for clients who wish to outsource the technical writing/editing of these documents. An additional fee applies. Please contact our Client Services department at 1-888-636-1062 or for additional information regarding this service.
25.Is Sponsor/CRO approval of site-specific consent revisions required prior to submission to Sterling IRB? Yes *No
*Note: When Sponsor/CRO approval is required, sites must provide confirmation of Sponsor/CRO approval with their submission. To assist in timely processing of site-specific consent submissions, please ensure that sites are aware of this requirement.
26. Please check to select all informed consent documentation that is being submitted with this protocol:
Participant Informed Consent Form (Adult Directed) Subject Information Sheet for Voluntary DNA Testing
Short Form Consent Form Pregnant Partner Data Release Form
Addendum to the Informed Consent Genetic Tissue Sample
Pharmacokinetics Pharmacogenetics
Assent Form for Minors Pharmacodynamics
Authorization to Use and Disclose Protected Health Parental Permission Form
Information (HIPAA) Assent Form for Adults Unable to Consent
Participant Information Sheet Consenting Script
Other (Please describe):
RECRUITMENT/RETENTION INFORMATION
27. What is the target number of subjects to be recruited for this study?28.What is the age range of the subjects being recruited for this study?
NOTE: Sterling IRB requires a separate age-appropriate assent form for children ages 7 through 11,
though Sponsors may electto broaden this range to include younger and/or older minors.
29. Will enrollment incentives or enrollment bonuses be offered? *Yes No
NOTE: Compensation to subjects for participation in the study is not considered an enrollment incentive
or enrollment bonus.
* If yes, please describe:
NOTE: Sterling IRB does not support the recruitment of subjects by payment for referrals to research
subjects or other persons,including, but not limited to, the Principal Investigator, Sub-Investigator
and Clinical Coordinator.
30. Are any recruitment materials being submitted at this time? *Yes No
NOTE: All recruitment materials must receive IRB review and approval. Sterling IRB requirements for
recruitment materials are outlined in the Investigator Handbook, available at
* If yes, what types of recruitment materials will be submitted at this time:
Print (i.e. newspaper, brochure, flyer) Website/Internet Use
Recruitment Letter “On Hold” Message
Radio Script TV Commercial (submit audio/video version)
TV/Video Script Radio Commercial (submit audio version)
Press Release Telephone Screening Script
Poster Other (please describe):
* If your submission includes a reference or link to a website, it is your responsibility to submit any research-related content,
including any information which pertains to a study under the review of Sterling IRB, for review and approval prior to use.
31. Are any study-related/retention materials being submitted at this time? *Yes No
NOTE: All study-related/retention materials must receive IRB review and approval.
* If yes, what types of study-related/retention materials will be submitted at this time:
Diary/Diaries Study Guide(s)
Questionnaire Study Card(s)
Subject Instructions Other (please describe):
Retention Incentive Materials
* If your submission includes a reference or link to a website, it is your responsibility to submit any research-related content,
including any information which pertains to a study under the review of Sterling IRB, for review and approval prior to use.
32. Is Sponsor/CRO approval of site-specific recruitment and study-related/retention materials required prior to submission to
Sterling IRB? *Yes No
Note: *When Sponsor/CRO approval is required, sites must provide confirmation of Sponsor/CRO approval with their submission. To assist in timely processing of site-specific recruitment and study-related/retention material submissions, please ensure that sites are aware of this requirement.
33. Is Sponsor/CRO approval required for site-specific audio and video recordings of previously approved study-wide recruitment
scripts? *Yes No
Note: *When Sponsor/CRO approval is required, sites must provide confirmation of Sponsor/CRO approval with their submission. To assist in timely processing of site-specific recruitment submissions, please ensure that sites are aware of this requirement.
NON-ENGLISH SPEAKING SUBJECTS/TRANSLATION