Easily Insert Data from the Clinical Trial Agreement

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How to Insert Data from 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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What is the difference between SDV and SDR clinical trials?

While source document verification (SDV) aims to compare recorded data against the source documents to ensure a match, the purpose of source document review (SDR) is to ensure the quality of the source documentation itself.

How do you collect data from a clinical trial?

Data in a clinical trial are generated and collected by: The investigator.Paper Case Report Forms (CRFs) Site staff can carry the CRF to wherever they need it. Site staff dont need to worry about access to computers and passwords. Relatively easy to amend if changes are required during the study.

Why do we need SDV in clinical trials?

Source Data Verification is a critical step in the clinical trial process. SDV is used to confirm that the source data is accurate and complete as it is collected, stored, shared, and analyzed. It helps ensure that your data will be reliable and can be depended upon for decision-making during your clinical trials.

What is source data agreement?

Source data is the first place the information is documented. Often a site will complete a source data agreement form to identify the source. The auditor verifies the following when conducting SDV or SDR during the audit: Informed consent form (ICF) is signed prior to any study procedures being conducted.

What does SDV mean in clinical research?

By definition, source data verification is the process of ensuring that the data reported for analyses accurately reflect the source data at the clinical trial site, a comparison of source data against the CRF data (transcription errors).

What is source data agreement in clinical trial?

What is source data? The executive order on GCP defines source data as any information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

Where is clinical trial data published?

Study results are often published in medical journals. On ClinicalTrials.gov, publication citations are displayed at the bottom of the Study Details tab of the study record, under the More Information heading.

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