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How to Send Clinical Trial Agreement

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well good afternoon everyone im david glaser and im just here to do a quick introductions and announcements uh and well turn it over to uh bob and katherine in a moment so our webinar our next webinar is on august 12th and the topic is going to be lessons from recent data bdocHubes and there have been some expensive lessons lots of seven figure lessons so this theyre going to talk about hipaa and otherwise katie ilton briar andreessen and lad will be doing it and theyre going to be talking so youre going to want to get your privacy and security people in on this so this is things like um you know uh how do you when you do it with how do you hire a vendor if theres been a data bdocHub what due diligence should you do on vendors to try to prevent data bdocHubes tips for dealing with bit data bdocHubes tips for dealing with the ocr on audits and settlement and having a good security policy so thats on august 12th same time a couple quick news announcements some of you may have heard

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Where can I publish a clinical trial?

Submit Studies to ClinicalTrials.gov PRS. ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent)

Does it cost money to participate in a clinical trial?

There are two types of costs in a clinical trial: patient care costs and research costs. Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trials sponsor.

How do you submit a clinical trial?

To register your clinical trial: Check to see whether your organization already has a PRS organization account . Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov. Logon to PRS on the PRS Login Page . Enter the required and optional data elements. Preview, inspect, and submit the record.

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

What is a clinical trial agreement?

A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.

How do I submit a clinical trial?

To register your clinical trial: Check to see whether your organization already has a PRS organization account . Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov. Logon to PRS on the PRS Login Page . Enter the required and optional data elements. Preview, inspect, and submit the record.

How do I submit a CTA?

Filing a CTA The CTA should be sent directly to the appropriate Directorate. The outer label should be clearly state Clinical Trial Application. Note: Where a sponsor wishes to make changes to the CTA under review, the sponsor should withdraw the active CTA and submit a new CTA .

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