Puerto Rico New Case Investigation Checklist

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Multi-State
Control #:
US-TS10063
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This form is a New Case Investigation Checklist usable in cases where licensing, patents, or commercial trade secrets are an issue.

How to fill out New Case Investigation Checklist?

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FAQ

Applicable Clinical Trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FDAAA.

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.

Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.

A clinical trial occurs in three parts: startup, maintenance, and closeout. The startup stage of the clinical trial includes the initial steps to getting the study up and running. This is an important phase of the process since clinical trials that get off to a good start are more likely to succeed.

(a) This part applies to the responsible party for an applicable clinical trial that is required to be registered under § 11.22, a clinical trial for which clinical trial registration information or clinical trial results information is submitted voluntarily in ance with § 11.60, or an applicable clinical trial ...

Startup phase consists of activities like CRF creation and Designing, Database designing and Testing, Edit checks preparation and User Acceptance Testing (UAT) along with document preparation such as Data Management Plan, CRF Completion Guidelines, Data Entry Guidelines and Data Validation plan.

The study start-up timeline can range from eight weeks to more than six months. One factor that influences the study start-up timeline is the ease of budget and contract negotiation and finalization. If there is a sticking point, the study may never move forward.

In Study Start Up (SSU) we support the start-up process and manage the critical path to site activation. SSU is one of the most complex and heavily regulated parts of any clinical trial or program launch.

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Puerto Rico New Case Investigation Checklist