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Creating a Clinical Data Management Plan to Satisfy FDA Inspectors

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Managing clinical data and documents has always been a challenge. But maintaining accuracy and integrity gets even tougher with multiple countries, sites and contractors cont

Managing clinical data and documents has always been a challenge. But maintaining accuracy and integrity gets even tougher with multiple countries, sites and contractors contributing data for a single product. Add in the potential for multiple protocol amendments, and the risks of failing muster with the FDA are even greater.

But what if you knew exactly what inspectors want to see? What if you could compare your own plan against the data management issues commonly cited in 483s?  And what if your people were armed with the know-how to anticipate and prepare for the questions inspectors ask?

You can do it all — starting right now!

In this resource from FDAnews, you’ll find what you must know to create a clinical data management plan that combines trouble-shooting best practices with insider intelligence of exactly what you’re likely to encounter during an FDA inspection.

From generating raw data and creating analysis datasets, to making final data available for FDA review, you’ll learn what it takes to pass muster. From Day 1 of your trial, the plan will empower your people, track, verify and communicate documents and data to ensure accuracy, integrity and the reproducibility of results. Plus, during the inspection, it will limit both confusion and questions.

Buy now to make sure you can prove the claims you make in regulatory filings by following a clinical data management plan the FDA will approve, including:

  • The essential elements: What the FDA must see covered in your plan.
  • What to avoid: How to structure your plan to avoid five common data management pitfalls that crop up in FDA 483s, including improper  document scanning or use of email, naming and other conventions, problems with SOPs and poor communication with contractors who generate data.
  • Hands-on guidance: Document the creation, alteration and validation of data.
  • Proactive preparation: How to build “inspection preparedness” into every aspect of clinical data and document management — from the very first day of your trial.
  • Interacting with FDA inspectors: How to control what your people say  — and don’t say, best practices for presenting data to the FDA, and tips for avoiding unnecessary confusion and questions.
  • Special considerations: Such as dealing with data from multiple countries and handling multiple protocol amendments.

Remember, FDA inspectors may arrive with or without advance notice. An inspection can be triggered by cause, as part of preapproval, or just as random surveillance. The time to prepare your plan — and your people — is now!

ributing data for a single product. Add in the potential for multiple protocol amendments, and the risks of failing muster with the FDA are even greater.

But what if you knew exactly what inspectors want to see? What if you could compare your own plan against the data management issues commonly cited in 483s?  And what if your people were armed with the know-how to anticipate and prepare for the questions inspectors ask?

You can do it all — starting right now!

In this resource from FDAnews, you’ll find what you must know to create a clinical data management plan that combines trouble-shooting best practices with insider intelligence of exactly what you’re likely to encounter during an FDA inspection.

From generating raw data and creating analysis datasets, to making final data available for FDA review, you’ll learn what it takes to pass muster. From Day 1 of your trial, the plan will empower your people, track, verify and communicate documents and data to ensure accuracy, integrity and the reproducibility of results. Plus, during the inspection, it will limit both confusion and questions.

Buy now to make sure you can prove the claims you make in regulatory filings by following a clinical data management plan the FDA will approve, including:

  • The essential elements: What the FDA must see covered in your plan.
  • What to avoid: How to structure your plan to avoid five common data management pitfalls that crop up in FDA 483s, including improper  document scanning or use of email, naming and other conventions, problems with SOPs and poor communication with contractors who generate data.
  • Hands-on guidance: Document the creation, alteration and validation of data.
  • Proactive preparation: How to build “inspection preparedness” into every aspect of clinical data and document management — from the very first day of your trial.
  • Interacting with FDA inspectors: How to control what your people say  — and don’t say, best practices for presenting data to the FDA, and tips for avoiding unnecessary confusion and questions.
  • Special considerations: Such as dealing with data from multiple countries and handling multiple protocol amendments.

Remember, FDA inspectors may arrive with or without advance notice. An inspection can be triggered by cause, as part of preapproval, or just as random surveillance. The time to prepare your plan — and your people — is now!

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