Protocol Submission Form

Transcription

1 Protocol Submission Form 1. Administrative Information Name of Submitting Party: Street: Province/State: Postal/Zip Code: Phone: ( ) Address: Fax: ( ) Other: ( ) Date: 2. General Study Information The normative framework of a research project may be influenced by its source of funding. In Canada most of the major research funding agencies (e.g., CIHR, NSERC, SSHRC, FRSQ, FQRSC, NATEQ) have adopted policy documents on the ethical conduct of research. Many of these policies refer to the Tri-Council Policy Statement (TCPS). Funding of institutions and researchers by these funding agencies is conditional on compliance with the TCPS. Similarly, researchers receiving funds from American funding agencies (e.g., NIH) must comply with the American Common Rule (45CFR46). Apart from governmental agencies, the private sector plays an essential part in the financing of research. Private sources of financing may either come from industry, community groups, or philanthropic organizations such as Canadian cancer foundations. Some private sponsors have adopted research and/or ethics guidelines that researchers may be obliged to follow. Sponsor of the Research: If Investigator - initiated, check here: Protocol Number: Protocol Title: Sponsor Type: Pharmaceutical or Biotechnology company Device manufacturer Canadian Federal Funding Agency (e.g. CIHR, NSERC) US Federal Funding Agency (e.g. NIH) Provincial or State Funding Agency (e.g. FRSQ) If there is no protocol number check here: t-for-profit organization Independent Consulting Firm University / Academic Institution Academic Medical Center Community Hospital Other (describe): Association Version/Date of Protocol (project): N/A Has the protocol/project been disapproved or terminated by another IRB? If, please explain. Include copies of any IRB correspondence. Is this protocol/project being transferred from another IRB? If yes, please explain Include copies of any. IRB correspondence. Page 1 of 8

2 3. Type of Research Type of Research: Biomedical (Indicate type: Drug Biologic Natural Health Product Device) Social/Behavioral* Tissue/Blood Bank* Chart Review* Other (describe): *Please complete Section c. a) For Drug/Biologic/Natural Health Product Studies Only Phase of Study: Other (describe): N/A Name of Test Article(s): Name of Comparator(s): Does the study include a sub-study? If, check all that apply: Pharmacokinetics/Pharmacodynamics Pharmacogenetics Other (describe): Will the Study be conducted in Canada? If, please complete Section 4.a. Will the Study be conducted in the United States? If, please complete Section 4.c. Is there a Data Monitoring Committee (DMC) or Data Safety Monitoring Board (DSMB) for this research? Name of Test Article(s): Name of Comparator(s): b) For Device Studies Only Does the study include a sub-study? If, check all that apply: Pharmacokinetics/Pharmacodynamics Pharmacogenetics Other (describe): Will the Study be conducted in Canada? If, please complete Section 4.b. Will the Study be conducted in the United States? If, please complete Section 4.d. Does the Protocol contain a Data Safety Monitoring Plan? (See the Veritas IRB s Guidance Document on Data Safety Monitoring Plan) Does the Study use diaries and/or questionnaires? If, please submit complete copies to the IRB for review c) For all studies N/A N/A Does the Study involve recordings (audio or video) of participants? If, please ensure that this is mentioned inthe Informed Consent Documentation. Please do not hesitate to contact us should you require assistance. Does the Study involve taking photographs of participants? If, please ensure that this is mentioned in the Informed Consent Documentation. Please do not hesitate to contact us should you require assistance. Page 2 of 8

3 4. Study Governance a) For Drug/Biologic/Natural Health Product Studies Conducted in Canada Is the drug, biologic or Natural health Product being used in this research study approved by Health Canada? If, is the drug or biologic being used in this study within its labeled indication? Has the Sponsor submitted a Clinical Trial Application (CTA) to Health Canada? If, please ensure to submit the n Objection Letter (NOL) to the IRB upon receipt. (The Veritas IRB will not provide its full approval of the Study before receiving a copy of the NOL.) If, describe the reasons why the submission of a CTA was not judged necessary: b) For Device Studies Conducted in Canada Is the device being used in this research study approved by Health Canada? If, is the device being used in this research study within its labeled indication? What is the Sponsor s device risk assessment? n-significant risk Significant risk Has the Sponsor filed an Investigational Testing Submission (ITS) to Health Canada? If, please ensure to submit the approval letter to the IRB upon receipt. (The Veritas IRB will not provide its full approval of the Study before receiving a copy of Health Canada s approval letter.) If, describe the reasons why the submission of an ITS was not judged necessary: c) For Drug/Biologic Studies Conducted in the United States Is the drug or biologic being used in this research study approved by the FDA? If, is the drug or biologic being used in this study within its labeled indication? Has the Sponsor submitted an Investigational New Drug (IND) to the FDA? If, Enter IND Number: Provide written confirmation once the IND has become valid. (The Veritas IRB will not provide its full approval of the Study before receiving written confirmation that the IND is valid.) If, describe the reason for exemption from the IND regulations per 21 CFR 312.2(b): d) For Device Studies Conducted in the United States Is the device being used in this research study approved by the FDA? If, is the device being used in this research study within its labeled indication? What is the Sponsor s device risk assessment? n-significant risk Significant risk Has the Sponsor submitted an Investigational Device Exemption (IDE) to the FDA? If, enter IDE Number: If, describe the reason for exemption from the IDE regulations per 21 CFR 812.2(c): Page 3 of 8

4 5. Investigational Sites How many investigative sites do you anticipate will use the ethics review services of Veritas IRB? What is the anticipated total number of investigative sites that will participate to the Study? Who will organize/coordinate IRB submissions? CRO Sponsor Site (PI) How will information that might be relevant to the protection of participants be managed? (Please check all that apply) Unanticipated problems will be reported in an expedited fashion to the IRB and its review will be conveyed to the sites by the person responsible for coordinating IRB submissions Protocol modifications will be submitted by the person responsible for coordinating IRB submissions who will then convey the IRB s decision to the sites Protocol deviations which involve the rights or the safety of participants and protocol deviation waiver requests will be submitted to the IRB in a timely manner and its review will be conveyed to the relevant sites by the person responsible for coordinating IRB submissions Other (please explain below) If Other, explain: Is emergency equipment/medication required on site by this protocol and/or sponsor? If, how will you ensure the PI/Sites comply with these requirements? Explain: 6. Participants Recruitment As part of its evaluation the IRB must verify that the Study has demonstrated equitable selection and recruitment of all research participants and have made every effort to ensure the fair distribution of the risks and potential benefits of participation in research and the diversity of participant selection. The IRB must ensure that the proposed sampling efforts do not favor some classes of participants and that any additional protection associated to proposed research involving vulnerable populations, such as children, cognitively-impaired individuals, pregnant women, and economically or educationally disadvantaged persons have been taken into consideration in the Study Documentation. Number of participants to be enrolled into this Study: Age range of participants* *NOTE: Studies that include participants who are minors over the age of 7 will require the addition of an Assent Statement and/or a separate Assent Form as well as a plan for how the assent will be documented with the submission of a study for review. Please do not hesitate to contact us should you require any assistance. Sex of the participants to be enrolled into this Study (check all that apply) Male Female Please indicate if the protocol design requires the enrollment of any of the vulnerable populations listed. (Check all that apply) Children/Adolescents (minors) Pregnant women Unemployed/Economically disadvantaged/homeless Students/Employees of researcher(s)/military members Cognitively impaired/mentally ill/ Decisionally impaired Seriously/Terminally ill Other (please explain below) If Other, explain: Does the protocol allow for non-english speaking participants? If, indicate which languages are anticipated and authorized by the Sponsor: Page 4 of 8

5 Will a central (generic) advertisement campaign and/or call center be used for this study? If, who will be organizing/coordinating the campaign? If, what types of advertisements will be included? (please check all that apply) Flyer Newspaper advertisement TV advertisement Poster Radio advertisement Web advertisement Is prior Sponsor approval of Investigator/Site generated recruitment material required? If, please instruct sites to obtain Sponsor approval prior to submission to the IRB. Are the Investigators going to recruit their own patients for this study? Will an enrollment incentive be offered? If, please provide details: Is competitive enrollment anticipated? If, please provide details: Will the participants receive acompensation for their participation (financial or other)? If, describe the amount and payment schedule of disbursement, including any amounts withheld pending completion of a particular portion of the study: 7. Study Contact Information a. Invoice Contact Payment for initial IRB review may be included with your submission, or we will prepare an invoice. Our payment terms are 30 days net. Please provide contact information for the individual who should receive ongoing invoices for ethics review services. If required, please include Purchase Order Number here: Payment Enclosed Please send invoice to the contact listed below Address 1: Address 2: Name: Title: Telephone: ( ) Fax: ( ) Address: Province / State: Postal / Zip Code: Page 5 of 8

6 b. Sponsor Contact Information Please provide contact information for the Sponsor Project Manager or Program Director for this study. This contact is the same information as in letter a. above. (If so, it is not necessary to complete this box again.) Address 1: Address 2: Name: Title: Telephone: ( ) Fax: ( ) Address: Province / State: Postal / Zip Code: c. Primary Contact Information: Sponsor/CRO (If applicable) Please provide contact information for the Primary CRO Contact for this study. This contact is the same information as in letter a. or b. above. (If so, it is not necessary to complete this box again.) Address 1: Address 2: Name: Title: Telephone: ( ) Fax: ( ) Address: Province / State: Postal / Zip Code: Original copies of the IRB communications will be sent to the Primary Contact via regular mail. How would you prefer receiving a copy of the IRB communications? By By Fax Would you like the Sites to be copied on all IRB correspondence (an additional fee may apply)? Page 6 of 8

7 d. Primary Contact Information: Site Contact (This section is for sites or institutions submitting directly to the IRB on their own behalf.) NA (multi-site studies submitted by Sponsor/CRO) This contact is the same information as in letter a. b. or c. above. (If so, it is not necessary to complete this box again.) Address 1: Address 2: Name: Title: Telephone: ( ) Fax: ( ) Address: Province / State: Postal / Zip Code: Original copies of the IRB communications will be sent to the Primary Contact via regular mail. How would you prefer receiving a copy of the IRB communications? By By Fax N/A Study Protocol Informed Consent Documentation. Template version. Participant Recruitment Procedure (e.g. Study Advertisements). Template versions. Written Information to be provided to Participants (e.g. questionnaires, diaries). Investigator s Brochure or Product Monograph Additional available safety information Data Safety Monitoring Plan (if not in the Study Protocol and required under the Veritas IRB s Guidance Document on Data Safety Monitoring Plan) Any relevant grant applications DHHS approved sample Informed Consent Document (if applicable) DHHS approved Study Protocol (if applicable) Page 7 of 8

8 Signatures The submitting party understands that Veritas IRB will conduct its review in material compliance with applicable laws, ethical standards and Veritas IRB Standard Operating Procedures (SOPs). By signing this form the submitting party hereby: Certifies that the information provided in the Protocol Submission Form is accurate; Agrees to conduct the Study in accordance with the guiding ethical principles and normative documents abided by the IRB (as presented on the IRB s webpage at as well as all applicable regulations; Acknowledges that Veritas IRB has the authority to review, oversee and suspend approval of the Study if necessary to protect the rights and welfare of research participants; Agrees to conduct the Study in accordance with the conditions of Veritas IRB, notwithstanding the Investigator or Sponsor s right to appeal a decision; Agrees to provide Veritas IRB with the information it requires to conduct initial and continuing review of the Study on atimely basis and acknowledges that if the information is not provided, Veritas IRB may suspend its approval of the Study; Acknowledges the right of Veritas IRB to conduct an audit of the Study s documentation and Informed Consent process if deemed necessary. Signature of the submitting party Date Page 8 of 8