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Investigational Agent Acquisition Program Affiliation:Director:Website:
Description:Goal: The goal of the CTSI Investigational Agent Acquisition Program (IAAP) is to assist CTSI investigators seeking investigational agents for use in clinical trials. Scope: The IAAP program will assist in acquiring drugs, neutraceuticals, biologics or other materials to be used in a Investigational New Drug Application or IND-exempt clinical trial. Eligibility: Any faculty within the CTSI member institutions. Overview: Moving bench research into the clinic has a variety of hurdles. One challenge repeatedly identified by investigators is the acquisition of novel products of interest that are suitable for use in clinical trials. For the most part, investigators have little or no experience in the regulatory requirements for an investigational agent; nor do they have expertise in identifying suitable vendors who can manufacture the required material. The manufacture of some materials, such as neutraceuticals, are generally straightforward and the IAAP can utilize its expertise to generate a roadmap and identify vendors for an investigator to consider. In other cases, for example when suitable active pharmaceutical ingredient (API) is not available, the manufacturing process is highly specialized, the properties of the material are not well characterized, or significant work will be required in defining a manufacturing plan and identifying a suitable production facility, consultants with specific experience must be engaged. The IAAP will meet with investigators, assess their needs and either facilitate the acquisition process or facilitate the hiring of outside consultants skilled in product acquisition. While advice will be provided, ultimately any decisions regarding the manufacturing plan and the acceptability of the material generated lies with the principle investigator. Therefore, users of the IAAP are expected to drive the process, providing requested information in a timely manner and maintain active interactions with consultants and manufacturers. Services:
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What should happen to unused investigational agents when the study is over?All unused investigational agents are expected to be returned to the sponsor at the: Termination site visit.
At which study visits can the site expect the sponsor to review subjects signed informed consent forms quizlet?At which study visits can the site expect the sponsor to review subjects' signed informed consent forms? Periodic and termination site visits. The subject informed consent forms are reviewed at the periodic site visits and the termination site visit.
When the sponsor investigator holds the IND for investigational drug he or she is responsible for annual reporting of which one of the following to FDA?The SI must submit an annual progress report to the FDA within 60 days of the anniversary date that the IND went into effect. This is the date the FDA permitted the study to begin and can be found on the FDA IND Acknowledgement Letter.
Who has ultimate responsibility for an investigational device at the site?1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.
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