Tag Archives: FDA guidance

Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

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Data Management Plan – Database Archive

Indicate how you intend to archive and share your data and why you have chosen that particular option.

The DMP should outline specific information regarding the organization’s procedures for archiving the electronic records.

Good practice for digital preservation requires that an organization address succession planning for digital assets.

Which criteria will you use to decide which data has to be archived? What should be included in the archive?

Type of data (raw, processed) and how easy it is to reproduce it. Also consider archiving audit trails as long as the records are (CRF Part 11, Section 11.10).

Does the archive have specific requirements concerning file formats, metadata etc.

It is recommended to use open source formats such as PDF-PDF/A, ODM-XML or ASCII type of files.

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Who is responsible for the data after the project ends?

Sponsor, CRO, Vendor? All should be documented on the DMP. Once database is locked, within a reasonable time and after data submission to a regulatory agency, you want to archive your database for long term storage and recovery.

While most data submitted to regulatory agencies are available in SAS formats, there may be times when going back to the original data format may be required.

Even though the easiest way to make sure data is available after database lock is to archive this data in the built in structure as the current system. For example, for Medidata Rave studies, trials are built on on top of SQL server, hence, you should consider archiving the old studies in a compatible format of SQL Server, without any transformation or data manipulation = raw data.

Other formats for data archive can be considered are ODM XML, PDF-PDF/A or ASCII A-8. These are some options for long=term storage. FDA says in the guidance document for 21 CFR Part 11, ‘scope and application – section C.5″, “FDA does not intend to object inf you decide to archive required records in electronic format to nonelectronic media….As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records”.

Archival Plan

For archiving data, this plan should list all the components of the orginal system that will be included in the archive and the formats being used for their storage.

The best practices for clinical data archiving in clinical research are no different from those for archiving any other kind of industry.

 

 

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

A Risk-Based Approach To Monitoring

A risk is any uncertain event or condition that might affect your project. Not all risks are negative.

No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Not all risks are negative
Some events (like finding an easier way to do an
activity) or conditions (like lower prices for certain
materials) can help your project! When this happens,
we call it an opportunity… but it’s still handled just
like a risk.

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Image Source: Head First PMP, by Jennifer Greene, PMP and Andrew Stellman, PMP

FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”.

Unfortunately, a lot of people in the industry are speaking about risk-based monitoring, but few have a broad understanding of the whole life-cycle process. Great opportunities exist for savings, but then again, most EDC platforms dont work effectively with risk-based monitoring. Switching to risk-based monitoring increases rather than decreases work because it can break the EDC workflow – refuting much of the value of EDC.

In conclusion, Risk-based monitoring is yet another desperate attempt to deal with what all Electronic Data Capture (EDCs) systems have failed to deliver – quality of clinical data.

Source: FDA Guidance

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

 

anayansi gamboa