Easily Delete Initials Field in the Clinical Trial Agreement

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How to Delete 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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When should the Delegation of Authority log be completed?

Prior to beginning research-specific tasks, the PI, with the assistance from the study team, will complete and keep current the Delegation of Authority (DOA) 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.

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 is a Section 801 clinical trial?

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal statute established in 2007 requiring the registration and reporting of information on applicable clinical trials on Clinicaltrials.gov.

What is required for a Delegation log?

The delegation log must reflect the current situation, showing what has been delegated to whom, with start and end dates. The PI must sign off each individual to show they are qualified by education, training and experience to perform their delegated duties. Evidence of appropriate training must also be included.

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 are the Alcoa C standards?

A common acronym in clinical research is ALCOA-C which stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. The purpose of ALCOA-C is to ensure that source documents are up to standard throughout every study.

What is a Delegation log?

The delegation of authority (DOA) log is a mechanism for tracking study team members over time. Those who are engaged in the research activity (including IRB approved study team members) need to be listed on the log.

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Reduce time spent on document administration and Delete Initials Field in the Clinical Trial Agreement with DocHub

A step-by-step guide on how to Delete Initials Field in the Clinical Trial Agreement

PDF editing simplified with DocHub

Drive efficiency with the DocHub add-on for Google Workspace

How to Delete Initials Field in the Clinical Trial Agreement

Got questions?

When should the Delegation of Authority log be completed?

What should be included in Delegation log?

Should the PI be listed on the Delegation log?

What is a Section 801 clinical trial?

What is required for a Delegation log?

Should the PI be listed on the Delegation log?

What are the Alcoa C standards?

What is a Delegation log?

See why our customers choose DocHub

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