Easily Delete Initials Field into the Clinical Trial Agreement

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How to Delete Initials Field into the Clinical Trial Agreement

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um Im excited today to kick off the fall clinical trials toolkit series um our first one is the office of sponsored programs clinical trial agreement review and negotiation um today we have Rachel humberson she is the interim assistant director um from research office and office of sponsored programs and we also have um Julie even though I practiced it Julie Im going to mess it up Anna okay is that right yeah okay she is a negotiator with research with the research office and office of sponsored programs um before I read their um their bios and a fun fact about them again we are offering continuing education to WVU employees so if um you would like CES please indicate that and please put your name um an email address in the chat so for attendance purposes um Im trying to think if theres anything else oh if you have a question during this um feel free to put it in the chat well be watching it and um I will stop Rachel and Julie and let them know what your question is and then also

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Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

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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.)

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.

Does the PI need to be listed on the DOA?

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 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 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 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 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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