|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 |