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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.

Hart Clinical Consultants Experiences Rapid Growth, Doubles Staff


Stan Reaves Also Named Chief Operating Officer

ATLANTA (January 13, 2016) – Hart Clinical Consultants (HCC), a specialized and adaptable Clinical Research Organization (CRO) that conducts and manages all aspects of novel medical device and pharma clinical trials, has announced it has more than doubled it’s staff over the past six months.

The expansion has brought with it changes to HCC’s executive team. HCC’s former Director of Business Development Stan Reaves, has been promoted to chief operating officer. As COO, Reaves will lead HCC’s national consortium of highly-trained clinical research professionals in providing study sponsors with comprehensive regulatory and clinical support services, including case proctoring, monitoring and audit functions. He is also responsible for HCC’s project management and training programs.

Stepping up to fill Reaves’s shoes in the business development role is Patric Mercer. Mercer’s primary focus as manager of business development is growth and oversight of sales and marketing operations for HCC and assisting with clinical trial operations. Prior to joining HCC, Mercer was a practice administrator and clinical research manager for SleepMed, Inc., where he was responsible for day-to-day operations of SleepMed’s clinical facilities and all aspects of its clinical trial operations.

“We are extremely grateful to have been able to acquire such industry-leading talent over the past several months,” said HCC CEO Jim Hart. “It makes our national network of clinical trial professionals even stronger.”

Within the past six months, HCC also added 11 senior clinical research associates (CRA’s) to it’s ranks, to include: Kari Anderson, Jill Barnes, Janice Boyd, Beth Davis, Cheryl Fink, Helen Gleason, JoAnn Key, Larry Lobacz, Bryan Petrisko, Susan Wilson and Carol Anne Yarbrough. HCC’s senior CRA’s are the company’s back bone and are responsible for a host of integral duties, including procedure proctoring, site management and monitoring as well as working directly with sponsors/clients – all to ensure compliance with clinical trial protocols and the scientific integrity of all data collected.

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventus, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

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