Easily Remove Initials Field in the Clinical Trial Agreement

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How to Remove Initials Field in the Clinical Trial Agreement

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hello everyone and welcome to the second ctis bite-sized talk on the initial clinical trial application my name is sarah scales im a change management officer here at ema and i want to first introduce the concept of the bite size talks today then ill explain a little a few housekeeping rules for the session before introducing the ctis experts who will be presenting today so on the concept of the byte size talks each bite-sized talk covers a specific ctis functionality and as seen on the agenda slide here the ctis experts will present the functionality and demonstrate it in the ctis application throughout the session there will be an opportunity to ask questions and if we go to the next slide youll see a few housekeeping rules so first of all we will be using slido as we typically do to collect questions for this event here on this slide you will see how to use slido you can go to w and use the event code march24 you can also use the qr code that youre seeing on your screen and as

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Should the PI be listed on the Delegation log?

All Clinical Research Site (CRS) staff and other individuals who have been delegated docHub study-related duties or tasks, which the Principal Investigator (PI)/Investigator of Record (IoR) would otherwise do, must be listed on the Delegation of Duties (DoD) log.

What should be included in delegation log?

Details: This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator. It is required for both observational and interventional clinical research studies.

Who is responsible for the delegation of duties log?

The IoR is responsible for the overall conduct of the trial. The IoR documents delegation of specific duties to site personnel using the DoD log. Any duties not delegated remain with the IoR; however, these duties do not need to be documented on the DoD log.

Who should be listed on delegation log?

All staff who have been delegated any task related to the protocol should be listed on this log. This includes PI, Sub-Investigators, Research Nurses and Coordinators, Research Fellows and Residents, Regulatory Coordinators, students (medical, dental, nursing, undergraduate, etc.)

What are the essential documents to be generated after completion or termination of the clinical trial?

DOCUMENTS NEEDED AFTER COMPLETION OR TERMINATION OF A CLINICAL TRIAL. Following completion of a trial, a comprehensive clinical study report (CSR) must be written that provides a detailed description of the results of the study, whether positive or negative.

Why do clinical trials have names?

The trial name reflects the brand strategy for the trial. Credible. The name does not overpromise and is acceptable to regulators.

What is PI delegation of authority?

The Delegation of Authority log (DoA) allows study specific tasks to be delegated to staff members by the Principal Investigator (PI). It is a comprehensive list of study team members which is established at the start of a study and maintained throughout the lifecycle of the study until study closure.

What should be included in Delegation log?

Details: This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator. It is required for both observational and interventional clinical research studies.

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