New Study Submission Application - Sterling IRB



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| |office 770.690.9491 toll free 1.888.636.1062 fax 770.690.9492 |

| |6300 Powers Ferry Road Suite 600-351 Atlanta, Georgia 30339 |

| | e-mail info@ |

New Study Submission Application

The New Study Submission Application is 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 accountrelations@) |

PRIMARY CONTACT INFORMATION

| |

|Primary contact for Sterling IRB: Sponsor CRO Investigator (Site/Institution) Other       |

| |

|Primary Contact Person:       |

| | |

|Street Address:       |City:       State:       Zip:       Country:       |

| |

|Phone/Ext:       |

|Email Address:       |

|Company and Position:       |

| | |

|Additional Contact Person:       |Email Address:       |

| |Company and Position:       |

|Phone/Ext:       | |

| |

|Notify when IRB issued documents are available in SilverLink?: Yes No |

| | |

|Additional Contact Person:       |Email Address:       |

| |Company and Position:       |

|Phone/Ext:       | |

| |

|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 Address:       |

|Email US Mail (to the billing 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 public department/agency(ies) funding or supporting this research:       |

| |

|*Note: If the research is supported or 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 risk and 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 sterlingirb,com 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 21 CFR 312.40, 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 days of 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 Letter or 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 provide Sterling 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 this |

|submission? |

|*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 adults in 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 |

|accountrelations@ 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 elect to 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

| |

|34a. Does the protocol allow for any non-English speaking subjects? If No, you may skip #34b-c. *Yes No |

| |

|* If yes, please indicate the translation process in questions 34b-c below. |

| |

|34b. Will any of the materials submitted require a language translation from Sterling IRB? *Yes No |

|* Please list the documents requiring translation or check “all”:       |

| |

|All materials submitted. |

|* Please select the desired language of translation (check all that apply): |

|Spanish Armenian |

|French Canadian Russian |

|Vietnamese Other (please list):       |

| |

|NOTE: There is an additional fee associated with a language translation. It typically takes up to 2-3 weeks for sites to receive |

|translated materials, dependant upon the length and/or complexity of the documentation. |

| |

|34c. Will any already translated materials be submitted to Sterling IRB at this time? *Yes No |

|*Please list the materials that are being submitted to Sterling IRB in a translated form at this time:       |

| |

|NOTE: Sterling IRB requires a copy of all translated materials and certification letters from a professional translation service in |

|order to approve the translated materials. |

CRITERIA FOR APPROVAL

| |

|Please ensure that your submissions meet each of the approval criteria listed below. Protocols that do not meet all of the following criteria will not be |

|approved. For further guidance, please refer to the Investigator’s Handbook. |

| |

|Risks to subjects are minimized. |

|Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to |

|result. |

|Selection of subjects is equitable. |

|Informed consent is adequate. |

|Documentation of informed consent (if required) is adequate. |

|Recruitment and direct advertising to solicit prospective participants is equitable and fair with respect to the recruitment procedures, and the methods of |

|advertising communication and advertising materials meet the federal requirements. |

|Payment arrangements, compensation, and costs to study participants are proportional to the commitments and degree of risk of the study, and payments are |

|promptly issued to study participants. |

|Where appropriate, the research plan makes provision for monitoring the data to ensure the safety of subjects. |

|Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. |

|Appropriate safeguards are included in the study to protect the rights and welfare of vulnerable subjects. |

|Scientific evaluation is sufficient and the research design carries enough likelihood of yielding data sufficient to warrant the risks to the subject. |

SPONSOR/CRO AGREEMENT

| |

|As an individual authorized to act in an official capacity for this study, I certify that: |

| |

|I have reviewed all of the responses provided in this New Study Submission Application. |

|All of the responses provided in this New Study Submission Application are, to the best of my knowledge, complete and accurate. |

|The Sponsor/CRO will act in accordance with the Sterling IRB-approved protocol, and will submit any protocol modifications and/or amendments for Sterling |

|IRB’s review and approval prior to implementation. This includes premature completion or cessation of a study. |

|The Sponsor/CRO will follow any applicable laws in the jurisdiction in which the research is conducted, and will abide by ethical standards for research and |

|clinical trials. |

|The Sponsor/CRO will stipulate who will provide any compensation available for medical care for research-related injuries. This information will be provided|

|on the Sterling IRB-approved consent form. |

|The Sponsor/CRO will promptly notify Sterling IRB of any findings obtained from on-site monitoring activities or from study results obtained as part of the |

|study or for two years after the study has closed that could affect the safety or medical care of a study participant or a study participant’s willingness to|

|continue participation in the study, influence the conduct of the study, affect the scientific design/integrity of the study, or alter Sterling IRB’s |

|determination of whether or how the study should be conducted. This may include findings arising from study sites not under Sterling IRB’s review. Sterling|

|IRB will determine whether and how the reported information, or part of it, should be provided to study participants (including former participants, where |

|appropriate) by the principal investigator or, in their absence, by the Sponsor/CRO. You agree to cooperate with Sterling IRB in carrying out its |

|determination. |

|I will assume the responsibilities Sterling IRB typically expects Sponsors/CRO to fulfill in regard to the reporting of study-wide information, if the |

|Sponsor/CRO will not have direct communications with the IRB. |

| |

|NAME OF PERSON COMPLETING THIS FORM: |

| |

|Printed Name:                           Company and Position:                           |

| |

|Date:                           |

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