An Alternative To The Free Online GCP Training by Quintiles

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Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

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Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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The Exemptee Institute
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Clinical Study Of Disulfiram To Reduce HIV Reservoir

Image via WikipediaThis caught my eye while scanning health news, Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals.

This ClinicalTrials.gov notice provides robust details about the research study, which is actively recruiting participants.

I find the basis for the study pretty interesting:

"Our primary hypothesis is that disulfiram will reduce the latent reservoir of HIV-1 in patients on highly active antiretroviral therapy (HAART). Theoretically, disulfiram will force HIV to replicate (grow) and thus result in the death of the infected cell. Standard antiretroviral drugs should prevent new cells from becoming infected. The end result of this process is that the total amount of HIV in the body will decline over time."

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Future Pills - Drugs, Devices, and More

An interesting intersection of drugs and medical devices, reported in this LA Times article, Smarter Pills - BEEP! BEEP! BEEP! This is your medicine. It's time for another dose.

In a nutshell,

"The goal: new devices to help people take their meds on time and improve the results coming out of clinical trials for new drugs."

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Univ of CA CMCR - Evidence Cannabis Is A Promising Treatment

Image via Wikipedia

The Center for Medicinal Cannabis Research: Report to the California Legislature (2010) - pdf reports:

"The CMCR has successfully conducted the first clinical trials of smoked cannabis in the United States in more than 20 years. As a result of this program of systematic research, we now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis."

Learn More:
Understanding Marijuana: A New Look at the Scientific Evidence

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HIV AIDS - 97 US Medicines in Testing - PharmaTimes

Image via Wikipedia

This is a really nice snapshot of some of the clinical testing going on in the HIV AIDS field, PhRMA's Pharmaceutical Researchers Are Testing 97 Medicines And Vaccines for HIV and Related Conditions. The article provides a quick overview for medicines grouped by:

1. Anticancer
2. Antiviral
3. Gene therapy
4. Immunomodulators
5. Vaccines
6. Other

Previous Posts: Abzymes Pinpoint The HIV Achilles Heel 109 HIV Drugs And Vaccines Under Development Listen To People With AIDS and HIV (audio)

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Is FDA Watching Over Cell Phones as Medical Devices?

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Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

---  original post follows below  ---

Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

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FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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Primer On Clinical Drug Studies

Updated May 30, 2025

The original link broke.

You might also like this podcast from the FDA on Clinical Trial Basics:

https://www.youtube.com/watch?v=brYANNYW8IY

---  the original post follows below  ---

Watch this free video and learn about, "Drug Studies: Who, What, When, Where, and Why."

UCTV says, "Almost every American takes a drug every day; many take three or more. This series presented by the UCSF Osher Lifelong Learning Institute explores your medicine, your health and your money. In this episode join John Flaherty, director of medical affairs at Gilead Science, Inc, as he explores the use of drug studies. Series: "UCSF Mini Medical School for the Public" [9/2007] [Health and Medicine] [Show ID: 13072] " 

Related Posts: Global Outsourcing - Clinical Drug Trials - Hot Debate 

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Global Outsourcing - Clinical Drug Trials - Hot Debate

Global outsourcing continues, and fuels some interesting debate, as evidenced by this recent New England Journal of Medicine (NEJM) article, "Ethical and Scientific Implications of the Globalization of Clinical Research." Of current interest, one of the author's name, Robert Califf, comes up as a candidate to lead the FDA. In CenterWatch's Clinicial Trials Today post, "Duke, NEJM Study Renews Debate on Global Outsourcing, they say "the NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems." 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It 

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Wow - FDA OKs Stem Cell Trial - This is a red letter day!

I'm thrilled to see some momentum gaining in this potentially rich area of clinical research. The U.S. Food and Drug Administration has granted clearance for Geron Corp. to begin trials for the world's first study of a human embryonic stem cell-based therapy for people. Geron said it will begin a Phase I multicenter trial designed to establish the safety of its treatment, currently referred to as "GRNOPC1," in patients with complete Grade A subacute thoracic spinal cord injuries. Read more details in this Medical News Today article, US Approves First Trial Of Embryonic Stem Cells.

I'm of the opinion that stem cell research has been stifled for way too long, and it's good to see the appearance of these studies. What's your opinion?

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FDA Data Guidance - When patients withdraw from clinical trials

How do you handle data when patients withdraw from clinical trials? For a well-written summary, read this post on the FDA Law Blog, "New Guidance Documents Available for When Subjects Withdraw from Clinical Trials." Thanks to Susan Matthees for writing this easily digestible article on the subject that includes links to the two guidance documents.

View more FDA Guidance Documents (free)

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Trackback url for the cited post above:
http://www.typepad.com/t/trackback/2294638/36853634

FDA Creates New Web Page of Drug Safety Information

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs, "Postmarket Drug Safety Information for Patients and Providers." On this page you'll find many resources organized in the following categories . .

• Drug Labeling
• Risk Evaluation and Mitigation Strategies (REMS)
• Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder
• Registries and Clinical Trials
• Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
• Latest Safety Information
• Reporting Problems to the FDA
• Warnings and Recalls
• Regulations and Guidance Documents
• Information about FDA's Drug Safety Oversight Board (DSB)
• Using Medicines Safely
• Consumer Articles on Drug Safety
• General Health Information
• FDA's Response to the Institute of Medicine's 2006 Report

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The FDA Drug Approval Process - free video

Updated May 23, 2025

The original link broke.

You might also be interested in the following FDA video:

https://youtu.be/fZ-Msidi7EE?si=rzphqPYBxwWlPgxV

---  the original post follows below  ---

For those of you wanting something a little more in-depth, here's this free 24 minute video, produced by peRX (prescribing evidence-based therapies), "Why and how are drugs approved?" Here's what the video presents . . .

1. Overview of drug research and development in the United States, and
2. The FDA drug approval process

A side note about peRX and this video. The peRX site states, "On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program." The peRX Project is an educational program funded by the Consumer & Prescriber Education grant program.

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4 Tips To Ensure Your Prescription Safety

Updated March 11, 2021

The original link broke.

People also search for:

Use Medicines Safely - Health.gov

---  original post follows below  ---

It seems as if I'm reading news everyday about some drug safety issue. Here are 4 great tips that you can personally act upon, in order to enhance the safety of prescriptions. For the full details, read this Reader's Digest article, "Prescription Drug Precautions - After a trend in recalled drugs, people are losing faith in the FDA. Find out how to ensure the safety of your prescriptions." In a nutshell, here are the 4 tips at a very high level . . .

1. Consider enrolling in a clinical trial as a volunteer (a kind of civic duty)
2. Stick with medications that have been around 4-5 years (the side effects are better known)
3. Report problems to the FDA
4. Urge legislators to provide greater funding to the FDA

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Merck - Pharma Gone Bad

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Updated September 27, 2016

The link in the original post finally broke.

You might also be interested in the following in-depth analysis of the same marketing project mentioned below:
When clinical trials are designed by the marketing department

- -  original post follows below  - -

This is all too sad. I suspect this is just the tip of the pharma iceberg. This is a prime example of ethical pharma gone bad. What I find the most fascinating is the internal company struggle between marketing versus bona-fide clinical trial staff. Read the full story in this LA Times news article, "Drug maker Merck's marketing project passed off as research, physicians say."

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The FDA Drug Approval Process

Updated July 15, 2020

The link in the original post broke.

You might also be interested in this:
Development & Approval Process | Drugs (on the FDA.gov website)

- - -  the original post follows below  - - -

I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.

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New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs

There was lots of coverage on this recently released FDA guidance, "Guidance for Industry - CGMP for Phase 1 Investigational Drugs. " (PDF) I'm posting the link to this guidance so that it can be easily found and downloaded. Here's what the introduction in the guidance says . . .

• This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).


• Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.


• This guidance replaces the guidance issued in 1991 titled Preparation of Investigational New Drug Products (Human and Animal) (referred to as the 1991 guidance) (Ref. 1) for the manufacture of phase 1 investigational drugs described in this guidance (see section III). However, the 1991 guidance still applies to the manufacture of investigational new products (human and animal) used in phase 2 and phase 3 clinical trials.


• The guidance finalizes the draft guidance entitled "INDs—Approaches to Complying with CGMP During Phase 1" dated January 2006; and is being issued concurrently with a final rule that specifies that 21 CFR part 211 no longer applies for most investigational products (see section III), including certain exploratory products (Ref. 2) that are manufactured for use in phase 1 clinical trials. The agency recommends using the approaches outlined in this guidance for complying with § 501(a)(2)(B) of the FD&C Act.


• FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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21 CFR Part 11 - Masking Real Data For Testing

Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.

Prior 21 CFR Part 11 Posts:
The Health, Drug, Prescription, and GMP Supersite: Resource List - FDA Part 11 - Electronic Records and Signatures

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FDA Will Exempt Phase 1 Drugs from GMP Regulations

• People also purchase FDA CGMP Online Training - recommended FDA GMP online training courses provided by SkillsPlus International Inc.

Good article on FDANews, "FDA Moves Forward With Exempting Phase I Drugs From GMPs." In the article, the agency is cited and says, "FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.”

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

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Job Opportunities in the GMP and Health Sector

• The best FDA cGMP online training courses and programs - Taught by SkillsPlus International Inc.

Updated March 4, 2022

As you can imagine, this 2008 posts just didn't age well.  Sorry.

You might also be interested in:

cGMP Jobs in the U.S. - LinkedIn

---  the original post follows below  ---

Pursue this list of jobs, and job hunting resources. Plan your career in the health, drug, and regulated industries (e.g., GMP, drug manufacturing) or look for your next job, consulting engagement, or opportunity amongst these job hunting links. Getting one of these jobs can put you in a place to influence, guide, and support ethical research and manufacturing of medical devices and drugs. 

• Bio Jobs - blog of biopharmaceutical jobs, tools, many topics
• Careers with i3global - the company of specialists
• cGMP Job Listings - by job-hunt.org
• Executive Recruitment Services - by Med Exec Intl. Jobs in clinical research, QA, medical affairs, regulatory affairs
• GMP Consultancy Opportunities from MasterControl
• GMP Job Listings - by CareerBuilder
• GMP Job Listings - by CareerJet
• GMP Job Listings - by Juju 
• GMP Job Listings - by MySpace
• GMP Job Listings - by SimplyHired
• GXP Job Listings - by GXP Recruiters
• i3 Pharma Resourcing - pharmaceutical personnel placement
• RegulatoryOpenings.com - Regulatory, QA, Clinical, and Medical Writing openings & jobs

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