Autofill Clinical Trial Agreement Template fast and easy

Straightforward instructions on how to Autofill Clinical Trial Agreement Template

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How to Autofill Clinical Trial Agreement Template

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The fall clinical trials toolkit series begins with a focus on clinical trial agreement review and negotiation. The session features Rachel Humberson, the interim assistant director from the Office of Sponsored Programs, and Julie, a negotiator from the research office. Continuing education credits are available for WVU employees who wish to participate; attendees should provide their name and email in the chat for attendance tracking. Participants are encouraged to submit questions in the chat, which will be addressed by the presenters during the session. Further details about the speakers' biographies and fun facts will follow.

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Do clinical trial agreements need to be part 11 compliant?

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The purpose of CFR Part 11 is to ensure the authenticity, integrity, and confidentiality of clinical trial data.

Can an eCRF be a source document?

Data elements can be transcribed into the eCRF from paper or electronic source documents. The authorized person transcribing the data from the source documents is regarded as the data originator. For these data elements, the electronic or paper documents from which the data elements are transcribed are the source.

Is a CRF a source document?

Case Report Forms Used as Source Documents Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.

Is a pathology report a source document?

In general the source documents in a hospital can include, but are not limited to, the following: Pathology Reports. Cytology Reports.

What is a CRF page?

A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study.

What are considered source documents in clinical trials?

Common source documents are participant medical records, phone encounters or notes, lab and diagnostic test results, participant diaries and specific research worksheets used to document key research data elements. If data are entered directly into a computer system, the electronic record is considered the source.

What are the components of a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

Is CRF A source data?

As the CRF is the first place that the data are recorded, the CRF is also considered source data. Note that data items collected directly for the purpose of the study (e.g. diary cards, participant-completed questionnaires) are also considered part of the CRF.

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Autofill Clinical Trial Agreement Template