Category : HCC Press / News


Hart Health Hints: January is National Blood Donor Month

Hart Health Hints:

January is National Blood Donor Month

Did you know that every two seconds someone in the U.S. needs blood?  Or that less than 10% of the population eligible to donate blood does so annually?

Although researchers keep trying, it is still not possible to manufacture artificial blood, making blood donations a necessity to supply patients with lifesaving blood products.

The American Red Cross (ARC), which supplies 40% of the nation’s blood supply, sponsors National Blood Donor Month every January, and this year is no exception.  The mission of the ARC this month is to raise awareness about the need for blood donations and to encourage people to donate.  Criteria for eligibility can be found here or here.  Even if you’re not eligible to donate your blood, consider volunteering with a blood bank to help with blood drives, donating to your local blood bank, or recruiting an eligible donor.

Donating whole blood only takes about an hour

Donating by apheresis takes about two hours, but individual blood components can be separated out of your blood, with the remaining put back in.  So, plasma, platelets, or red blood cells can be extracted from your blood individually and the other components are left in your blood.

There is even a mobile app to help speed up the process. One, called simply, Blood, can help you schedule and track your donations, and even allows you to earn rewards from participating retailers. Another app, called RapidPass, allows you to save time donating by starting the donation process at home.    There is a wide range of free Red Cross apps including information to help you in case of an emergency. To find first aid, pet first aid, and disaster information, go here.

So this January, consider doing something to help save one of the millions of patients who need blood every year.  Think about National Blood Donor Month and commit to doing one small thing:  make a donation of your blood, your time, or some cash. Make a family day of it. After all,  it may be a family member, a friend, or you that needs a blood transfusion one of these days.

From all of us here at HCC, have a wonderful January, and stay warm!


Essential documents Deep Dive: The clinical protocol and amendments

Hart’s Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents, and we looked specifically at the Investigator brochure in our last glossary post. In today’s post, we will dive a bit deeper into what is required for a clinical study protocol.

The guideline defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guidance, the term protocol refers to protocol and protocol amendments”.  The definition for a protocol amendment is, “a written description of a change(s) to or formal clarification of a protocol.

Protocol and its amendments are the map to a clinical study.  These documents lay out the plan for the study and for continent plans if things don’t go according to plan.  They form the blueprint for each study’s conduct for the sponsor, sites, IRB/EC, and regulatory agencies to gauge the scientific merit and likelihood of successful execution for each study.

Section 6 of the guideline provides the minimum information that should be included in a clinical protocol and suggests options for its layout.  Site-specific information, pre-clinical background information, or other required information may be contained is separate documents that are referenced within the study protocol.  These may include documents such as the investigator brochure, statistical analysis plan, monitoring plan, financial contract, or insurance, etc.

For details on the preparation of a study protocol and amendments, please see the E6 guideline, here. Generally, a protocol (or its reference documents) should include the following:

  • General information
  • Background information
  • Details about the objectives and purpose of the trial
  • Trial design details
  • Selection and withdrawal of study participants
  • Treatment of study participants
  • Assessment of efficacy
  • Assessment of safety
  • Statistics
  • Assurance of direct access to source data and documents for monitoring, audits, IRB/EC review, etc.
  • Quality control and quality assurance
  • Financing and insurance
  • Publication policy
  • Supplements

The protocol should have an area for the primary investigator’s signature, which asserts that the trial will be conducted in compliance with the protocol, good clinical practices, and all applicable regulatory requirements.  All protocol amendments should include revision numbers, dates, and the primary investigator’s signature.

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at advertisements used during a trial.

ALCOA. A framework for quality

Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of him. His personal shortcut for tenets of data quality was ALCOA, but when he ran out of space on a slide one day, he included the acronym. After that, it stuck.



Some dread it.

Others create it.

Either way, you know it is inevitable.


The clinical research industry is no exception. Ever since James Lind’s famous scurvy trial in 1747,1 where he demonstrated the affliction could be cured by the consumption of oranges and lemons, the concepts, tenets, and processes of modern clinical research have been evolving. This is no different today, with the global clinical trials market estimated to grow 7.5% annually to approximately $22 billion USD by the year 2021. Of that, medical device clinical trials are expected to contribute about a third, making transformation of the industry unavoidable.

Global politics, shifting regulations, and technological innovations–all big picture drivers of change– influence not only manufacturers of medicines and medical devices, but the consumers of these products as well. Economic factors affect markets, which drive changes to industry directly and indirectly via changes in regulations. Improvements in technology provide an impetus for changes to processes and efficiency.

These are our top predictions of what is in store for the clinical research industry.



Hart Health Hints: November is American Diabetes Month

Join us as we recognize American Diabetes Month this November. This year, the campaign aims to raise awareness about the 29 million Americans with diabetes and to create a sense of urgency about this growing public health crisis. Approximately 1.4 million Americans over 20 are diagnosed with diabetes every year.  It remains the 7th leading cause of death, with 69,071 deaths caused by diabetes and 234,051 death certificates with diabetes listed as a contributing cause of death.  The disease costs the Unites States approximately $245 billion. For more diabetes statistics, go here.