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What is IP accountability log in clinical trials?

Investigators are responsible for maintaining strict control over investigational devices to ensure that the device is used only for subjects enrolled in the study. The Device Accountability Log helps maintain study device inventory.

Who has the ultimate responsibility for the administration dispensation of an investigational product at the clinical site?

Responsibility for accountability for investigational products/study drugs (IP) at the trial site rests with the investigator/PI, although where allowed/required the investigator may/should assign some or all of his/her duties to an appropriate pharmacists or another appropriate individual under his/her supervision.

What is product accountability?

This is meant to establish the mindset that in order to evaluate a Product Manager's and Product Team's performance it's not about delivery it's about the performance of their product relative to the goals of the organization over time.

Which document must be signed when dispensing an investigational new drug?

Required Forms (§§ 312.23(a)(1), 312.53(c)) 176 177 Form FDA 1571 Investigational New Drug Application 178 179 Under § 312.23(a)(1), a sponsor-investigator's initial IND submission must be accompanied by a 180 signed Form FDA 1571 Investigational New Drug Application (Form FDA 1571).

Who is responsible for the investigational product?

Investigational Product(s) 4.6. 1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.

who has the ultimate responsibility for the administration dispensation an investigational product at the clinical site

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What is an accountability log?

The Drug or Device Accountability Log is a means to track and document when and how the investigational product (drug or device) has been used throughout the study.

Who is responsible for the accountability of investigational product's at an investigator site?

1: \u201cResponsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.\u201d However, the sponsor is not off the hook, since the sponsor must ensure that the investigator is maintaining compliance with the regulations (21 CFR 812.40, 21 CFR 312.50), which of course, ...

Where is investigational product dispensing information recorded?

The packing slip, shipment tem- perature records, and any other documents received with the investigational product shipment shall be stored in the pharmacy study-specific file. All investigational drug products received must be documented on a DARF.

Who is responsible for drug accountability at the study site?

Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. The Investigator is responsible to ensure control of investigational product.

What is IP accountability in clinical trials?

General Responsibilities: It is the responsibility of the Principal Investigator (PI) at the site of a clinical trial to ensure accurate and complete accountability and proper storage of investigational drugs/products used in a clinical trial.

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