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Delete Page Numbers into the Clinical Trial Agreement

Delete Page Numbers into the Clinical Trial Agreement

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Aug 6th, 2022

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How to Delete Page Numbers 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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Got questions?

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.

What is the NCT identified number?

ClinicalTrials.gov identifier The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is NCT followed by an 8-digit number (for example, NCT00000419).

What is a protocol number in clinical trials?

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

What is a unique protocol identification number?

Unique Protocol Identification Number * Definition: Any unique identifier assigned by the sponsor to refer to the availability of its investigational product for expanded access use or to identify the expanded access record. Limit: 30 characters.

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.

What are the number phases involve in clinical trials?

There are 3 main phases of clinical trials phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.

What documents should be in a TMF?

Investigator Brochure (IB) and/or Summary of Product Characteristics and any updates. Certificate of Analysis of IMP(s) Instructions for handling the IMP (if not already in the IB) Treatment allocation and decoding documentation (for blinded trials) Drug delivery/return records (e.g. Shipping documents) Sample labels.

What is a number attached to each clinical trial protocol?

Registry Identifier: Number assigned by a clinical trial registry (for example, a registry that is part of the World Health Organization [WHO] Registry Network); also required to enter the name of the clinical trial registry.

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.

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