Multicenter Initial Study Application

|SECTION 1: GENERAL STUDY INFORMATION |
|a. |Sponsor: | |b. |Protocol | |
| | | | |Number: | |
|c. |Study | |
| |Title: | |
|SECTION 2: TEST ARTICLE INFORMATION |
|a. |Test Article | |
| |Name: | |
|b. |Test Article | Drug | Biologic | Food / | Diagnostic| Social / |
| |Type: | | |Drink | |Behavioral |
|c. |Does this study involve a radioactive drug? |
| | Yes – please provide a copy of approval by a Radioactive Drug Research |
| |Committee. |
| | No | |
|d. |Test Article | Marketed (and study does not involve investigational use) |
| |Status: | |
| | Investigational – please note the following|IND | |
| |instructions: |#: | |
|Please support your IND # by submitting one of the following: (1) the Sponsor |
|protocol with the IND # on it; (2) a letter from the Sponsor; (3) a letter from the |
|FDA. If you have not obtained an IND #, please submit an explanation as to why not. |
|e. |Study | Phase I | Phase II | Phase III| Phase IV | Other:| |
| |Phase: | | | | | | |
| |
|SECTION 3: IRB REVIEW INFORMATION |
|Has this protocol been disapproved or terminated by another IRB prior to submission |
|to Aspire IRB? |
| | Yes – list the name of the IRB(s) and the outcome of the review(s) on a |
| |separate page. |
| | No | |
| |
|SECTION 4: SPONSOR INFORMATION |
|Contact | |
|Person: | |
|Company: | |
|Address: | |
| | |
|City: | |State| |Zip | |
| | |: | |Code: | |
|Phone | |Fax | |Email| |
|Number: | |Number: | |: | |
| |
|SECTION 5: CONTRACT RESEARCH ORGANIZATION (CRO) INFORMATION |
|None |
|Contact | |
|Person: | |
|Company: | |
|Address: | |
| | |
|City: | |State| |Zip | |
| | |: | |Code: | |
|Phone | |Fax | |Email| |
|Number: | |Number: | |: | |
| |
|SECTION 6: CONTACT INFORMATION |
|Please indicate the name of the contact person to be copied on all IRB correspondence|
|to sites: |
|Name:| |Company: | |
| |
|SECTION 7: MAIL DELIVERY INFORMATION |
|NOTE: All documents will be delivered via First Class US Mail unless otherwise |
|instructed. |
|a. |Would you prefer overnight courier delivery of approval documents? |
| | No – go to | Yes – complete remainder of |Is this same method to be used |
| |SECTION 8 |SECTION 7 |for site documents? Yes No |
|b. |Service | FedEx DHL UPS | |
| |Provider: |Other: | |
|c. |Account | |Reference | |
| |Number: | |Number: | |
| |
|SECTION 8: BILLING INFORMATION |
|Please provide the correct name and address of the person who will be responsible for|
|payment of services rendered. |
| Same as Sponsor | Same as CRO | Other:| |
|Contact | |
|Person: | |
|Company: | |
|Address: | |
|City: | |State| |Zip | |
| | |: | |Code: | |
|Phone | | Fax | |Email| |
|Number: | |Number: | |: | |
|NOTE: Any changes to the above information must be emailed to Michele@aspire-irb.com |
|SECTION 9: FUNDING INFORMATION |
|Is this study federally-funded or subject to a federalwide assurance (FWA)? |
| Yes – please note that Aspire IRB does not accept federally-funded research or |
|research that is subject to an FWA. |
| No |
|SECTION 10: SITE INFORMATION |
|a. |How many total sites will be involved | |
| |in this study? | |
|b. |How many sites will be utilizing Aspire IRB as| |
| |their IRB? | |
| |
|SECTION 11: SUBJECT ENROLLMENT INFORMATION |
|a. |What is the subject enrollment goal for | |
| |the study/protocol? | |
|b. |Please provide the anticipated dates for the following events: |
|First subject | | Last subject | |Last subject | |
|enrolled: | |enrolled: | |completed: | |
|c. |Please indicate whether the protocol design requires/includes the enrollment of |
| |any of the vulnerable populations listed below. Check all that apply. For all |
| |populations checked, please describe any additional safeguards included in the |
| |protocol to protect the rights and welfare of these subjects. |
| Children / minors (NOTE: 19 is the age of | Employees of the PI/site and/or their |
|majority in Alabama |immediate |
|and Nebraska; 21 is the age of majority in |family members |
|Puerto Rico.) | |
| Pregnant women / fetuses | Students of the PI/site |
| Economically and/or educationally | Terminally ill individuals / |
|disadvantaged |individuals with |
|individuals |life-threatening conditions |
|SECTION 11: SUBJECT ENROLLMENT INFORMATION (continued) |
| Nursing home residents / institutionalized| Limited or non-readers / illiterate |
|individuals |individuals |
| Comatose individuals / traumatized | Hearing / visually impaired |
|individuals |individuals |
| Decisionally impaired individuals |
| Other (specify): |
| Non-English speaking individuals – complete questions 1, 2 and 3 below. |
|1. |Would you like Aspire IRB to arrange for translation of the consent form(s)?|
| | Yes No |
| | |
|2. |For which language(s) do you need the translation(s)? |
|3. |Are there any additional items (e.g., recruitment materials, subject |
| |diaries) for which you would like Aspire IRB to arrange for translation? |
| | Yes – please list all items for which translation is requested: |
| | No |
| Do not anticipate the recruitment/enrollment of any subjects from vulnerable |
|populations. |
|d. |Will the use of Legally Authorized Representatives (LARs) be permitted in this |
| |study? Yes No |
|SECTION 12: SUBJECT RECRUITMENT METHODS |
|NOTE: All subject recruitment materials (including telephone screens) must be |
|approved by the IRB prior to implementation. |
|Please indicate all anticipated subject recruitment methods: |
| None | Print | Radio | TV | Newsletters| Flyers | Internet | Other:| |
| |
|SECTION 13: CONFIDENTIALITY AND HIPAA INFORMATION |
|”Confidentiality” refers an individual's wishes as to how his/her identifiable |
|private information will be handled, managed, and disseminated. Confidentiality is a |
|means of protecting that information, usually by safeguarding it from unauthorized |
|disclosure. |
|a. |Please indicate any provisions included in the protocol to maintain subject |
| |confidentiality: (check all that apply) |
| | Paper based records will be kept in a secured location and only accessible to |
| |personnel involved with the study. |
| | Computer based files will be password protected and only be made available to |
| |personnel involved with the |
| |study. |
| | Study personnel will be required to sign statements agreeing to protect the |
| |security and confidentiality of study |
| |information prior to being granted access to any study related information. |
| | When feasible, identifiers will be removed from study related information. |
| | Other – provide an explanation. |
|b. |Will personnel not directly related to the research have access to study records |
| |or data (billing office, medical records, hospital personnel, etc.)? |
| | No Yes – provide an explanation |
|c. |Will you be submitting HIPAA language for review? |
| | No Yes – submit as a separate HIPAA authorization form or as a clearly |
| |identified HIPAA section in the |
| |Informed Consent Document. |
|d. |If any of your study sites are covered entities, will you require a partial |
| |waiver of authorization in order to screen for the study? |
| | No Yes – provide the IRB with your rationale for this need. |
|SECTION 14: PRIVACY INFORMATION |
|”Privacy interests” refer to an individual's interest in having control over the |
|extent, timing, and circumstances of sharing oneself or information about oneself |
|with others. |
|a. |Will personal information collected from subjects be limited to only that which |
| |is necessary for study purposes? |
| | No – attach an explanation. Yes |
|b. |Are there any additional provisions included in the protocol to protect the |
| |privacy of subjects? |
| | No Yes – attach a description. |
|SECTION 15: SITE MONITORING INFORMATION |
|Please indicate how sites will be monitored for this study (check all that apply): |
| Telephone – | |
|frequency: | |
| Routine On-site Visits – | |
|frequency: | |
| For Cause On-site Visits – explain | |
|criteria for selection: | |
| Other – | |
|explain: | |
| |
|SECTION 16: DATA AND SAFETY MONITORING INFORMATION |
|Are there provisions in place for data and safety monitoring? |
| No – please provide a rationale explaining why such provisions are not necessary. |
|Please note: studies determined to be more than minimal risk are required to have |
|provisions in place for data and safety monitoring. |
| Yes – please answer the following questions: |
|a. |Who will monitor the data? |
|b. |What data will be monitored? |
|c. |How frequently will data be monitored? |
|d. |What analyses will be performed on the data? |
|e. |What decision rules (e.g., stopping rules) will be considered? |
| |
|SECTION 17: IND SAFETY REPORTS |
|IND Safety Reports submitted by the Sponsor / CRO will be acknowledged to the main |
|study file only. The Sponsor / CRO is responsible for providing copies of the |
|acknowledged IND Safety Report to individual sites. |
|OPTIONAL SERVICE: |
|For an additional fee, Aspire IRB can provide site-specific acknowledgement letters |
|for IND Safety Reports to each individual site. If you would like this optional |
|service, please check here: |
| |
|SECTION 18: INITIAL STUDY CHECKLIST |
|The following information must be included with your complete application by the |
|submission deadline in order to be guaranteed placement on the agenda: |
| |
|Protocol supported by a valid IND # (if applicable) |
|Investigator's Brochure (IND studies) OR Package Insert (FDA-approved drugs) |
|Sample Informed Consent Document (disk / electronic) |
|Other necessary information |
| |
|SECTION 19: SPONSOR/CRO AGREEMENT WITH ASPIRE IRB |
|On behalf of the Sponsor/CRO, I am requesting that Aspire IRB review the information |
|submitted. I understand that Aspire IRB accepts responsibility for providing IRB |
|oversight of this research. I understand that Aspire IRB has the right to conduct a |
|site visit at any time with proper notification. On behalf of the Sponsor/CRO, I |
|agree to promptly report any information that becomes available that may affect the |
|safety of subjects, subject's willingness to participate, or the IRB's approval to |
|continue the study. |
|Authorized by: | | |
| | | |
|PRINTED NAME |SIGNATURE |DATE |
| | |
|TITLE |COMPANY |
|( ) – | |
|TELEPHONE NUMBER | |EMAIL ADDRESS |