SAMPLE LETTER OF UNDERSTANDING
Medical Center Name: __________________________________
Medical Center Number: ________________________________
“Protocol or Study Name”
This letter reflects the understanding between __________________ (hereinafter referred to as “Department of Veterans Affairs (VA) Affiliate”) and the VA Medical Center at __________________ regarding the circumstances under which the VA Affiliate agrees to provide study drug to the VA Medical Center for the following research study _________________________, “____________________________________” (“Protocol or STUDY”). A copy of the Protocol, dated ___/___/___, is attached and incorporated herein by reference.
The VA Medical Center Pharmacy Service ____________ __________ will serve as a liaison between VA Affiliate and the VA investigator and will act as the central control and distribution center for donated drugs for the STUDY. Pharmacy Service will provide guidance and information regarding study drugs as well as serving as a conduit for communications between the VA Affiliate and the Food and Drug Administration (FDA) when appropriate.
The VA Affiliate will provide _(Insert Drug name and strength)_ and matching placebo (hereafter referred to as “Study Drug”) for the STUDY in accordance with the following provisions.
The VA Medical Center at _______________________ and the VA Affiliate have agreed upon the following operating procedures in connection with the STUDY and this Letter of Understanding:
1. Conduct of the STUDY. The VA Medical Center at ________________________ will conduct the STUDY in accordance with the terms of Protocol and within VA guidelines with the participation of the VA Affiliate.
2. Drug Supply, Distribution, and Accountability. The VA Affiliate will supply Study Drug for the duration of the STUDY, free of charge, and will include in planning allowances for wastage that may unavoidably occur during dispensing. The VA Affiliate will provide shipment of Study Drug directly to the Pharmacy Service in accordance with the schedule agreed to by both parties. The Pharmacy Service will label and dispense Study Drug and keep all records of drug disposition. The Pharmacy Service warrants that in its processes the Study Drug shall not be adulterated or misbranded, in accordance with the Food, Drug and Cosmetic Act. Pharmacy Service agrees to use the Study Drug supplied by VA Affiliate only for the investigational purposes authorized under the Protocol. No other use of the drug will be permitted by Pharmacy Service. In the event that the Pharmacy Service has unused Study Drug at the time the STUDY is completed or terminated, the Pharmacy Service will dispose of Study Drug in accordance with operating procedures outlined by the VA Affiliate.
3. Safety Information Reporting. The local investigator is responsible for reporting adverse events with respect to Study Drug to the VA Affiliate and/or FDA in conformance with all applicable laws, rules, and regulations in effect.
a. The local investigator must provide to the VA Affiliate any information on any serious adverse event, side effect, injury, toxicity, sensitivity reaction or any unexpected incidence and the severity thereof related to the Study Drug that is associated with its “clinical” use in accordance with the Protocol. “Serious Adverse Events,” as used in this context, have the meaning ascribed thereto in the Protocol. All such events deemed to be related to the Study Drug must be reported to the VA Affiliate on Protocol SAE forms within ________ business days of receipt by the local investigator.
b. It is understood and agreed that these adverse events reporting requirement provisions are based upon the VA Affiliate’s respective policies and procedures and regulatory reporting requirements. Accordingly, in the event of changes to VA Affiliate’s policies and procedures for adverse events reporting, the local investigator agrees to comply with such revised notification requirements as reasonably requested in writing by the VA Affiliate. This is provided that the scope and extent of activity and undertakings are not materially increased. The VA Affiliate agrees to pay all costs associated with this request.
4. Early Study Termination. The STUDY may be terminated at any time by the Investigational Review Board for safety or efficacy reasons if it is thought to be in the best interests of the patients. Either the VA or the VA Affiliate may withdraw support from the STUDY with 90 days written notice only if this agreement has been violated.
5. Patient Confidentiality. Patient confidentiality will be maintained at all times in accordance with applicable law and VA policy. Reports issued for public distribution or to the VA Affiliate will contain only aggregate data with all patient identifiers removed.
6. Selection of Participants. The VA Medical Center at __________________________ will be responsible for all decisions concerning the selection and/or discontinuation of participants in the STUDY.
7. Record Retention. The VA Medical Center at ________________________ shall retain all records related to the STUDY for a minimum period of 3 years from the date of the last patient follow-up. At that point the STUDY records will be evaluated for archiving.
8. Term of Agreement. This agreement shall be effective as of the date last signed below and shall expire upon completion of all activities related to the STUDY as defined by the submission of the final STUDY report to the VA Affiliate and the primary publication of the STUDY results.
9. Modification to Agreement. This agreement can only be modified in writing and would require signatures by the VA Medical Center at ______________________ and VA Affiliate representatives.
10. Approval. The following signatures indicate approval of the terms of this letter of understanding.
___________________________________________________ ___________________
(Name and Signature of the PI) (Date)
___________________________________________________
(Name of the VA Affiliate)
___________________________________________________ ___________________
(Name and Signature of the VA Investigator) (Date)
___________________________________________________
(Name of the VA Facility)
Medical Center Name: __________________________________
Medical Center Number: ________________________________
“Protocol or Study Name”
This letter reflects the understanding between __________________ (hereinafter referred to as “Department of Veterans Affairs (VA) Affiliate”) and the VA Medical Center at __________________ regarding the circumstances under which the VA Affiliate agrees to provide study drug to the VA Medical Center for the following research study _________________________, “____________________________________” (“Protocol or STUDY”). A copy of the Protocol, dated ___/___/___, is attached and incorporated herein by reference.
The VA Medical Center Pharmacy Service ____________ __________ will serve as a liaison between VA Affiliate and the VA investigator and will act as the central control and distribution center for donated drugs for the STUDY. Pharmacy Service will provide guidance and information regarding study drugs as well as serving as a conduit for communications between the VA Affiliate and the Food and Drug Administration (FDA) when appropriate.
The VA Affiliate will provide _(Insert Drug name and strength)_ and matching placebo (hereafter referred to as “Study Drug”) for the STUDY in accordance with the following provisions.
The VA Medical Center at _______________________ and the VA Affiliate have agreed upon the following operating procedures in connection with the STUDY and this Letter of Understanding:
1. Conduct of the STUDY. The VA Medical Center at ________________________ will conduct the STUDY in accordance with the terms of Protocol and within VA guidelines with the participation of the VA Affiliate.
2. Drug Supply, Distribution, and Accountability. The VA Affiliate will supply Study Drug for the duration of the STUDY, free of charge, and will include in planning allowances for wastage that may unavoidably occur during dispensing. The VA Affiliate will provide shipment of Study Drug directly to the Pharmacy Service in accordance with the schedule agreed to by both parties. The Pharmacy Service will label and dispense Study Drug and keep all records of drug disposition. The Pharmacy Service warrants that in its processes the Study Drug shall not be adulterated or misbranded, in accordance with the Food, Drug and Cosmetic Act. Pharmacy Service agrees to use the Study Drug supplied by VA Affiliate only for the investigational purposes authorized under the Protocol. No other use of the drug will be permitted by Pharmacy Service. In the event that the Pharmacy Service has unused Study Drug at the time the STUDY is completed or terminated, the Pharmacy Service will dispose of Study Drug in accordance with operating procedures outlined by the VA Affiliate.
3. Safety Information Reporting. The local investigator is responsible for reporting adverse events with respect to Study Drug to the VA Affiliate and/or FDA in conformance with all applicable laws, rules, and regulations in effect.
a. The local investigator must provide to the VA Affiliate any information on any serious adverse event, side effect, injury, toxicity, sensitivity reaction or any unexpected incidence and the severity thereof related to the Study Drug that is associated with its “clinical” use in accordance with the Protocol. “Serious Adverse Events,” as used in this context, have the meaning ascribed thereto in the Protocol. All such events deemed to be related to the Study Drug must be reported to the VA Affiliate on Protocol SAE forms within ________ business days of receipt by the local investigator.
b. It is understood and agreed that these adverse events reporting requirement provisions are based upon the VA Affiliate’s respective policies and procedures and regulatory reporting requirements. Accordingly, in the event of changes to VA Affiliate’s policies and procedures for adverse events reporting, the local investigator agrees to comply with such revised notification requirements as reasonably requested in writing by the VA Affiliate. This is provided that the scope and extent of activity and undertakings are not materially increased. The VA Affiliate agrees to pay all costs associated with this request.
4. Early Study Termination. The STUDY may be terminated at any time by the Investigational Review Board for safety or efficacy reasons if it is thought to be in the best interests of the patients. Either the VA or the VA Affiliate may withdraw support from the STUDY with 90 days written notice only if this agreement has been violated.
5. Patient Confidentiality. Patient confidentiality will be maintained at all times in accordance with applicable law and VA policy. Reports issued for public distribution or to the VA Affiliate will contain only aggregate data with all patient identifiers removed.
6. Selection of Participants. The VA Medical Center at __________________________ will be responsible for all decisions concerning the selection and/or discontinuation of participants in the STUDY.
7. Record Retention. The VA Medical Center at ________________________ shall retain all records related to the STUDY for a minimum period of 3 years from the date of the last patient follow-up. At that point the STUDY records will be evaluated for archiving.
8. Term of Agreement. This agreement shall be effective as of the date last signed below and shall expire upon completion of all activities related to the STUDY as defined by the submission of the final STUDY report to the VA Affiliate and the primary publication of the STUDY results.
9. Modification to Agreement. This agreement can only be modified in writing and would require signatures by the VA Medical Center at ______________________ and VA Affiliate representatives.
10. Approval. The following signatures indicate approval of the terms of this letter of understanding.
___________________________________________________ ___________________
(Name and Signature of the PI) (Date)
___________________________________________________
(Name of the VA Affiliate)
___________________________________________________ ___________________
(Name and Signature of the VA Investigator) (Date)
___________________________________________________
(Name of the VA Facility)
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