New Study Submission Application - Sterling IRB
|[pic] | |
| |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: |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
Related searches
- irb submission requirement
- new york nclex application status
- new york nclex application form
- what is the irb process
- new york nclex application requirements
- irb board requirements
- irb review board requirements
- new york nursing application status
- when is an irb required
- irb submission requirements
- new york rn application status
- sample irb application submissions