Modify design in the protocol

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How to Modify design in the protocol

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hello everyone and welcome to protocol design what you need to know to ensure a successful study presented by roe Im Carly health an editor at Pierce pharma and Ill be moderating this webinar our speakers today are dr. David shoemaker Im your vice president of RD and dr. Karen Kessler assistant vice president of operations you can read their full BIOS on the right side of your window just a few technical notes where we begin if you have trouble reading a slide please hold and drag the right corner of the slide window to enlarge please also disable your pop-up blocker to participate in the interactive parts of this presentation if youd like to download the slide deck please click the purple globe at the bottom of your screen this webinar is being recorded and will be available on demand within 24 hours after the event we will follow the presentations by a QA session please submit your questions during or after the presentations using the QA box at the right of your window okay no

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Got questions?

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What are the responsibilities of sponsor and investigator in clinical trials?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in ance with the general investigational plan and protocols

What is the responsibility of a sponsor-investigator?

The sponsor-investigator is responsible for ensuring all participating investigators provide the SI with sufficient accurate financial information to allow the SI to submit complete and accurate certification or disclosure statements.

What are the reasons for protocol amendments?

Factors leading to Protocol amendments Amendments occur in case of new Study dose information, variation in sample size, adverse events or serious adverse events, protocol design discrepancies, lower recruitment rates, changing regulatory demands all of these factors are responsible for changing the protocol.

What is a protocol design?

A protocol design or research proposal is a written plan of the research. The protocol design can have any format or template. As long as the protocol design contains the necessary information the protocol is good.

When can investigator deviate from protocol?

Protocol deviations occur when an investigator does not implement or follow some aspect of a research study as approved by the IRB. All deviations reflect a failure to comply with the approved study and as such, are instances of potential noncompliance and must be reported to the IRB.

What actions must a sponsor investigator take to make changes in the protocol?

A sponsor shall submit a protocol amendment for a new protocol or a change in protocol before its implementation. Protocol amendments to add a new investigator or to provide additional information about investigators may be grouped and submitted at 30-day intervals.

What is the term used to describe changes to a protocol?

Protocol Amendments A written description of a change(s) to or formal clarification of a protocol. Protocol Deviations Failure to conduct a study as described in the protocol.

What are substantial changes in protocol?

Amendments to the trial are regarded as substantial where they are likely to have a docHub impact on: the safety or physical or mental integrity of the subjects, or the scientific value of the trial, or the conduct or management of the trial, or the quality or safety of any IMP used in the trial.

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