TMF Reference Model Update

March 18, 2012

TMF RM

The Trial Master File (TMF)

The recommended and required contents of the TMF, the trial master file, continue to be a concern for clinical trial professionals. This blog continues to support the efforts of the DIA working group for the TMF Reference Model, originally issued in 2010. The most recent updates to the TMF RM within Version 1.2, which was released in December 2011, featuring TMF components at the clinical sites along with those kept by the sponsor. The next version of the TMF RM is planned for release in June 2012. There is expected to be some updated content as a result of feedback received from broad industry use of the model, in addition to extension arms of the model for device and investigator-initiated trials. In this Guest Commentary, Lisa Mulcahy, co-chair for the TMF RM working group, explains the basics of the TMF RM.

The Trial Master File Reference Model

The Trial Master File (TMF) Reference Model (RM) is a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA), a recognized and highly respected professional association. Creation of the TMF Reference Model has involved more than 230 representatives, all DIA members, from more than 150 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, non-for-profit / NGO and regulatory agencies. The attention of participants is drawn to the non-commercial nature of this forum. Although it is acknowledged that the resulting reference model ultimately needs to integrate with commercially available products, this was by no means a forum for promotion of products and companies.

The TMF RM was first released in June of 2010 and is a reference for the biopharmaceutical research industry. The model clearly outlines the content and organization of TMF content, at both Sponsor and Investigator site. TMF RM is a reference for the industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry. The TMF RM can be adapted to an electronic or a paper TMF and does not endorse, nor by design, require, any specific technology for application.

The goal of the TMF RM is to provide a single, unified interpretation of the regulations via document listing which would be accepted across the industry. It does not provide guidance in the process by which the document is the output.

Use of the model

The uptake of the TMF RM is broad and it is at a minimum being used as a tool to compare against sponsor already-defined TMF content. It is most often though being adapted or adopted by companies as it provides a comprehensive listing of content created in support of a clinical trial.

Rationale for the creation of a model

The TMF contains those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements (ICH Guideline for Good Clinical Practice, E6, Section 8).

TMF Reference Model

ICH E6

Regulatory guidance, such as ICH E6 section 8, addresses only a sub-set of TMF documents. Documentation requirements for the set-up and maintenance of quality systems, electronic systems, safety monitoring, and proof of an adequate and well-controlled trial, to name a few, exist in various regulations across many countries or regions, but not in ICH E6.

The following are additional reasons for creation of the TMF RM

• All companies and investigators conducting clinical trials in the pharmaceutical/biotech industry maintain documentation for each clinical trial. Each company has their own unique TMF structure as defined by their SOPs. No comprehensive common model exists for managing TMF documents. Over the conduct of a trial many functions contribute to the TMF, although oversight of the content is usually not one function’s responsibility – resulting in a highly inefficient work processes including but not limited to:

• All drug development companies and CROs expend considerable resources defining the content of the trial master file for each clinical trial. Consequently, Investigators have the challenge of adapting to different formats and TMF content organization with each clinical trial.

• The burden is very high on smaller companies that usually have limited document management expertise and limited financial resources.

• Records and information exchange between collaborating companies is extremely cumbersome, potentially preventing the joint venture or transfer of an investigational product.

• Regulators are challenged with varying terminology and file structures, creating inefficiency and variability during audits
Organization of the model

TMF

TMF Artifacts

Defined in the model are document types, called artifacts, which one would expect to find in a TMF, at both Sponsor and Investigator site. The artifacts are labeled either core, meaning it must be in the TMF as dictated by either the ICH Guidelines, regulations, or the TMF RM group (if applicable for the trial), or recommended meaning the artifact does not have to be produced but if it is created or collected, it is recommended to be in the TMF. Since the industry often uses unique names, alternate names (as relevant) and descriptions are supplied for each artifact. If the artifact is referenced in the ICH Guidelines, this information is captured.

The artifacts have been organized by Zone – where like artifacts are grouped together:

• Zone 1 Trial Management
• Zone 2 Central Trial Documents
• Zone 3 Regulatory
• Zone 4 IRB/IEC and Other Approvals
• Zone 5 Site Management
• Zone 6 Investigational Product (IP) and Trial Supplies
• Zone 7 Safety Reporting
• Zone 8 Centralized Testing
• Zone 9 Third Parties
• Zone 10 Data Management
• Zone 11 Statistics

Artifacts are created and can exist at multiple levels such as trial, country, and site. An artifact, such as “Safety Management Plan” exists at only 1 of the levels, the trial level. In contrast, the artifact “Informed Consent” can exist at all three levels. These levels can be used to define the paper format TMF.
The TMF RM can be found, free to the public using the following link (cut and paste into web browser address bar:

Metadata

The TMF reference model also details basic metadata which can be used as a starting point for building TMF electronic content management processes. This metadata model can be applicable in all electronic settings, from the straightforward file share to the complex enterprise system.

TMF Reference Model

"This model is designed to capture the unique set of documents"

The trial number is captured on each of the artifacts in the TMF RM. Since this model is designed to capture the unique set of documents associated with a single trial, the trial number is attached to each artifact. Inherited metadata such as Product/Compound, Indication, Trial Phase, and Route is also attached to each artifact and would be required to be entered only once, dependent upon system design.

Date format and convention for which date is captured on an artifact present on every artifact and has been left to those interpreting the reference model within already defined processes. Artifacts would have country metadata associated with them if they were to be created for a specific country and a site number/ID if created at the site level.

Lisa Mulcahy

The TMF RM Online

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Please join your industry colleagues in completing the 2012 TMF Reference Model Survey, and use results to inform your TMF best practices.

https://www.surveymonkey.com/s/FPP8DCF

This fifteen minute survey is designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results.

Data collection closes June 1st; please join us today.

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======== A GxP Perspectives Editorial ========

It came as a surprise that Wikipedia, under Electronic trial master file, has a subjective entry regarding the TMF RM. Regarding the TMF RM it states: “it fails to specify any electronic format for consistent document and record exchange.” It then goes on to suggest another group is doing a better job: “In an effort to resolve the obstacles around the electronic exchange, sharing and interoperability of electronic trial master files, http://www.etmf.org eTMF.Org was formed in 2011 to develop a standard for the secure exchange and sharing of eTMF archives…” This is an organization that lists four experts on its website. This is in contrast to over one hundred industry professionals, including myself, who have worked over the past few years on the TMF RM.

Wikipedia can be a useful research tool when the articles are objective and well researched. This article is currently rated 3.6 of a possible 5.0 for objectivity. You can read it for yourself, and rate it accordingly at the following link.

Wikipedia eTMF Article

GxP Perspectives welcomes all comments on the TMF and the efforts by the TMF RM working group and others on the best way to advance a coherent, usable TMF guidance.

Carl Anderson, GxP Perspectives

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Join the GxP Perspectives Linkedin Group Here

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FDA has issued the final guidance, “IRB Continuing Review after Clinical Investigation Approval.” GCP Guidance Documents may be found here: FDA GCP Website. The new guidance is on the right in the section “In The News.”


TMF: Reference Model Explained

October 3, 2010

TMF Reference Model

What Documents are Necessary for a Clinical Trial?

Guest Commentary: A discussion on the trial master file (TMF) Reference Model presented to this summer’s annual meeting of the Drug Information Association (DIA). As clinical trials have evolved, regulatory authorities and GxP professionals have discussed the need for clear definitions and examples of the documents necessary for effective clinical trials. DIA began an effort to try and determine what would work in a globalized clinical trial environment. The result is the TMF Reference Model. While it is a work in progress, the TMF Reference Model has helped many clinical trial professionals determine how to record the data necessary to support a regulatory submission. This Guest Commentary by Karen Redding helps explain the concept of the TMF Reference Model.

Guest Commentary by Karen Redding

What is the TMF Reference Model?

The TMF Reference Model (TMF RM) is a single, unified interpretation of the regulations in the form of a list of TMF artifacts which would be accepted by all clinical trial stakeholders and which can be adopted or adapted by any company, institution or organization. It does not provide guidance in terms of the process by which the artifact is created or collected. It extends beyond regulatory guidance, such as ICH E6 section 8, which addresses only a sub-set of documents required in a TMF.

Who is sponsoring the reference model?

TMF Reference Model Explained

The TMF Reference Model
is a DIA Project

The initiative to create a TMF RM is supported by the Document and Records Management SIAC of the Drug Information Association (DIA). The TMF RM team consists of more than 130 representatives from 91 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, non-profit / NGO and regulatory agencies.

What is the structure of the reference model?

The TMF RM consists of standardized taxonomy and metadata and outlines the clear definition and organization of TMF content using consistent nomenclature. It is emphasized that this model is a reference and should not be considered mandatory, but rather as an opportunity for harmonization and alignment across the industry. The TMF RM can be adapted to an electronic or paper based TMF and by design does not endorse, nor require, any specific technology for application. The document types defined in the model are called artifacts. Version 1 .0 was released on 4th June 2010.

What are the key questions we are trying to answer in the upcoming meetings?

Collectively, the members of the TMF RM experience the same challenges, and many of these directly result in sub-groups being set up to provide a collective opinion. Current questions include:

1. How much does TMF management actually cost a company, how can we measure it, and how can we improve efficiencies?

2. What requirements need to be met to allow for a paperless environment, can we destroy scanned paper, can we retain documents in electronic form only?

3. Many studies are contracted to CROs, how much documentation needs to be maintained by the Sponsor to show oversight, and how is this oversight defined?

How do you get more information on the reference model? Is there a non-commercial website?

TMF Reference Model Explained

How To Get Involved With The TMF Reference Model?

The TMF RM group meets by teleconference every 3 weeks to discuss issues such as those above. Various sub-committees exist such as the Communications, Metrics, Paper Management and Review team, and these groups meet separately to discuss the specific aspects assigned to them. Many documents are published in the DIA Web Office. In addition, there is a LinkedIn group and a blog. You are invited to follow TMF RM activities on LinkedIn by joining the TMF Reference Model group.

The TMF blog address

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Please join your industry colleagues in completing the 2012 TMF Reference Model Survey, and use results to inform your TMF best practices.

https://www.surveymonkey.com/s/FPP8DCF

This fifteen minute survey is designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results.

Data collection closes June 1st; please join us today.

=====

Two Important New GCP Documents: There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

///
UPDATE: My favorite industry magazine, Applied Clinical Trials, now has a LinkedIn Group:
Applied Clinical Trials LinkedIn
///

++++ In News From GxP Perspectives++++

TMF Compliance Documents from FDA

GxP Perspectives on the TMF

ALSO: Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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TMF Update: FDA References on Certified Copies and Original Data

August 25, 2010

FDA reference original data and certified copy

FDA References for Original Data & Certified Copies in Clinical Trials

As clinical trial professionals try to comply with FDA requirements on electronic records there are a number of documents that are referred to that are hard to find. One is the Compliance Policy Guide # 7150.13 referred to in the definitions section of FDA Guidance Document: Computerized Systems Used in Clinical Investigations (May 2007). It is referenced in the description of “Original Data.” FDA states: “FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provided the copies are identical and have been verified as such.” FDA also has a definition of “Certified Copies” in the same guidance document.

Here are some links that will be of use in researching original data and certified copies:

Compliance Policy Guide 130.400 (equivalent to 7150.13)

Betterchem Link on Compliance Policy Guide

Applied Clinical Trials: CDISC Clinical Research Glossary

Read the Final Guidance from the European Medicines Agency on Electronic Data Capture:

EMA Reflections

Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

In news from GxP Perspectives read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

Announcement: TMF Webinar 14 October

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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TMF Reference Model Presented to DIA

August 9, 2010

TMF FDA documents

TMF Reference Model Announced

The Trial Master File (TMF) Reference Model was presented to the annual meeting of the Drug Information Association (DIA) in Washington, DC in June. There has been a lot of confusion lately as different regulatory agencies have enforced clinical trial TMF requirements in different ways. The TMF Reference Model was developed by the DIA Document and Records Management TMF Reference Model Working Group and at least one major regulatory agency is taking a close look. The Reference Model utilizes Section 8 of the ICH GCP Guideline (E6) Essential Documents as the core “artifacts” for the TMF. They also have recommended artifacts. As sponsors move from paper to electronic and as TMFs become more complex, it is hoped that the reference model can help determine what documents are necessary to satisfy regulatory requirements for clinical trial documentation.

At the Avandia Advisory Committee meeting FDA discussed the TMF publicly for the first time that I am aware of with regards to a sponsor inspection. Anecdotally I know that FDA field investigators are now auditing the TMF. Sponsors and CROs need to review their TMF procedures and document control if they expect FDA to feel that data integrity is a component of their application. Hopefully, the Reference Model developed by DIA will help.

There is a LInkedIn group that discusses the reference model that can be found at:

TMF Reference Model LinkedIn Group

GxP Perspective Post on Reference Document

UPDATE 30 April 2012:

Please join your industry colleagues in completing the 2012 TMF Reference Model Survey, and use results to inform your TMF best practices.

https://www.surveymonkey.com/s/FPP8DCF

This fifteen minute survey is designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results.

Data collection closes June 1st; please join us today.

=====

Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

Read the Final Guidance from the European Medicines Agency on Electronic Data Capture:

EMA Reflections

Update: Read the blogster in Applied Clinical Trials

ALSO: Please join me at:

GxP Perspectives LinkedIn Group

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Reflecting on the Trial Master File, the TMF

February 5, 2010

Post updated 28 January 2011: Just what is a trial master file or TMF? What are “Essential Documents?” How does FDA expect to see researchers document a clinical trial? Are there differences between FDA and EMA, the European Medicines Agency in TMF requirements? UPDATE: Read the Final version of the “EMA Reflections” Document on EDC, released after this post was originally published.

Reflecting on TMF

Documentation Requirements for Clinical Trials

It is interesting to note that although “TMF” is a standard industry term in the United States and is used by regulators around the world, the FDA doesn’t actually have a TMF inspection and rarely uses the term. FDA regulations are vague about the exact documents required for a clinical trial. In a response to an inquiry about documents answered by “GCP Questions,” a program within the Office of the Commissioner, FDA stated on 02 November 07:

“FDA’s regulations are intentionally pretty general, the reason for this is that the agency believes that sites and sponsors should have the necessary flexibility to adopt procedures that will comply with the regulatory requirements, and make sense (given the complexity of the study and available staff), without being unnecesarily burdensome.”

While this may be a commendable intent, it isn’t particularly helpful. I understand that regulations and guidance documents can’t be overly specific, but vague guidance on regulatory compliance leads to what I call, “regulation by rumor.” People will use an anecdote they have heard about what they think an FDA investigator wants in order to determine what documents FDA considers essential to a clinical trial. This can cause real problems between a clinical site and a monitor or auditor. There are genuine differences on how to document protocol deviations and other issues.

trial master fileThe term “trial master file” comes from the ICH E6 Guidance Document on Good Clinical Practice (E6). (Links to E6 and other documents related to this post are listed at the conclusion of the post.) Section 8 of E6 is called, “Essential Documents for the Conduct of a Clinical Trial.” In the introduction to Section 8 the Trial Master File is discussed. I consider E6 to be the authoritative document on the subject. Section 8 has a comprehensive list of Essential Documents, their location and what is necessary before, during, and after a clinical trial. When I define “TMF” I use the documents listed in Section 8 as my primary guidance. The only significant addition to this list (that I am aware of) is the FDA requirement for a Final Report, from the investigator to the sponsor. (I have an article on Final Reports at the conclusion of this post.)

TMF Trial Master File

ICH E6 Sets the Standard for Essential Documents

However, some regulatory authorities don’t seem to be emphasizing E6 as much as they may have in the past. It has been suggested that there might be additional “Essential Documents” although no regulatory agency that I know of has published a comprehensive list that could complement E6. Also, it has been suggested that there may be a “Good Clinical Practice” standard other than E6. FDA stated this when they rewrote the requirements for Foreign Clinical Studies Not Conducted Under an IND (21 CFR 312.120). Where you can find an alternative GCP isn’t discussed.

I think that E6 gives sound recommendations for GCP compliance. We should be using it more, not less. It has been published in the Federal Register as official FDA Guidance. It is the only guidance that FDA has on the TMF.

When discussing the TMF one of the trickiest issues involves electronic records, including electronic medical records (EMRs) at a hospital or medical center. There is a lot of grey area as far as protecting privacy, access to EMRs, and the validation of an institution’s EMR system. Unfortunately there isn’t a definitive guidance document on the topic of EMRs. FDA does have a guidance document on “Computerized Systems Used in Clinical Investigations.” It is found in the Important References section on your right, along with E6. Another resource that I recently became familiar with is a document from EMEA with the clever name of “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.” I’ve attached a PDF copy for your viewing pleasure at the bottom of the post. It contains some excellent recommendations. (Also attached is the final document released after this post was originally written. It is very similar: See “EMA Reflections”)

TMF electronic records

Electronic Medical Records

The “Reflections” document discusses Assigning Responsibility for maintaining clinical trial records. FDA regulations assign responsibility to either the sponsor or the clinical investigator. The “Reflections” document notes that the clinical site needs to maintain control over source documents and not hand over the responsibility to a sponsor. Source documents are the responsibility of the clinical investigator. This includes worksheets or standardized forms that a sponsor might prepare for a site in order to conduct the study according to the protocol. Even though the worksheets are written by the sponsor, they become the Responsibility of the Investigator. Lately FDA has taken to making this point on Warning Letters. Here’s an example from a recent FDA Warning Letter to a clinical investigator on the subject of “adequate and accurate subject case histories.”

“Your site chose to use the sponsor’s standardized forms as source documents to record and document information related to the subjects’ study visits. Per the standardized form, your site was to “Complete the Inclusion/Exclusion Criteria Worksheet to evaluate for study eligibility.” In the FDA investigator’s review of 16 of 65 subject records at your site, there was no Inclusion/Exclusion Criteria Worksheet found for any of these subjects.”

TMF FDA warning letters

Notice FDA's Wording in Warning Letters

Notice that FDA considers that the site “chose” to use the sponsor’s forms. These records are the responsibility of the clinical investigator. As such, if there is a problem with them during an FDA inspection, then the problem belongs to the clinical site. In this case, the problem was significant enough to result in a Warning Letter. Having solid documentation of a clinical baseline, including recording the Inclusion/Exclusion Criteria are Very Essential Documents. It should be noted that this clinical investigator had a lot of additional problems, not just the sponsor’s standardized forms, or worksheets.

The EMA “Reflections” document gives some good advice for clinical trial recordkeeping. They use the old FDA guidance ALCOA- Attributable, Legible, Contemporaneous, Original, and Accurate and add four additional elements. They are Complete, Consistent, Enduring, and Available When Needed. The last point is particularly important. If you can’t show the document to a regulatory inspector, then for the purposes of the inspection, it doesn’t exist. I would add one additional element; QUALITY. People sometimes place importance on fax coversheets, which are not Essential Documents, instead of the quality of the source documents that document a clinical baseline and protocol-required activities.The quality of the documents used to support an application for a new drug or medical device is sometimes overlooked, to the detriment of Good Clinical Practice. These are the documents used to protect human subjects in research and ensure data integrity. Their quality should allow them to “stand alone.”

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—-
Updates posted 28 JAN 2011- Read about the Academy of Medical Research Report by Nick Taylor in Outsourcing-Pharma

UPDATE 28 JAN 2011: There is a very interesting Important Notice to IRBs that is on the FDA website. Sort of a Coast IRB redux.

UPDATE 6 January 2011: Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

References:

Update: Read the Final Reflections Paper from the European Medicines Agency on Electronic Data Capture:

EMA Reflections

Also: There are a couple of very good comments to this post by experienced professionals. They are well worth reading.

Here is the E6 document:
E6_ICH_GCP

Here is the FDA guidance document on “Computerized Systems Used in Clinical Investigations.

Here are some links that will be of use in researching original data and certified copies:

Compliance Policy Guide 130.400 (equivalent to 7150.13)

Applied Clinical Trials: CDISC Clinical Research Glossary

And finally on Notes to File:

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=500437

Please remember, your comments, questions, complaints, and advice are always welcome !!!

++++In news from GxP Perspectives++++

Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA. And Again in 2012!

2012 CAPAs in the GCP Environment

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

Share/Bookmark

Read additional posts on Good Clinical Practice- GCP:

https://carl1anderson.wordpress.com/category/gcp/


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