Promoting Excellence in the Field of Clinical Research through Education and Exchange

SOCRA

• 15,300+ Members
• 11,100+ "CCRP" Certified Clinical Research Professionals
• 40+ education programs scheduled in 2017
• 75+ examination sites scheduled in 2017

The 26th Annual Conference:
October 6 - 8, 2017
Disney's Coronado Springs Resort
Orlando, FL

Upcoming Events

SOCRA Highlights

• 2017 Election Results

  2017 Election Results are in!  Thank you to all members who voted in this year's election!

• Final rule enhances protections for research participants, modernizes oversight system

  The Office of the Federal Register pre-published the long-anticipated revisions to the Common Rule

• 2016 Annual Conference Poster Program Finalists

  Congratulations to SOCRA’s 2016 Poster Program Finalists. One hundred and thirteen participants presented posters at the 2016 Annual Conference in Montreal, QC.

  View the list of finalists.

• Draft Guidance: Use of Electronic Health Record Data in Clinical Investigations
  The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations.

  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf
• NIH and FDA Request Public Comment on Draft Clinical Trial Template for Phase 2 and 3 IND/IDE Studies

  The National Institutes of Health (NIH) published a Notice in its Guide to Grants and Contracts seeking public comment on an instructional and sample text template that NIH funded investigators may use in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. The draft template was developed by the NIH and the Food and Drug Administration (FDA) with the goal of ensuring that investigators prepare protocols that are consistently organized and contain all the information necessary for the clinical trial to be properly reviewed.  The draft template also follows the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. 

  Comments will be accepted through April 17, 2016

• SOCRA CCRP Program Receives NCCA Accreditation

  SOCRA has received NCCA accreditation of its CCRP Program by demonstrating the program’s compliance with the Standards for Accreditation of Certificate Programs. This Accreditation ensures that SOCRA not only achieves but surpasses its mission of establishing an internationally recognized certification program for clinical research professionals (CCRP®).

   

• SOCRA 2015 Salary Survey

  The 2015 Salary Survey is available for review.

  The results and analysis can be found here

• Draft guidance for use of investigational tobacco products

  http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM463953.pdf
  

• Health Canada Online Consultation - request for (your) comment

  "Protecting Canadians from Unsafe Drugs Act" -  Transparency Needs-based Assessment

  Started on March 26, 2015, and available through May 25^th, 2015, Health Canada is conducting a "Needs-based Assessment" to evaluate end users' transparency needs. The results of this consultation will be used to modify the way information is disseminated to stakeholders, and for the development of new regulations.  To access the online questionnaire (answering it should take only 10 or 15 minutes) please click on the following web link or paste it into your browser. http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_unsafedrugsact-lesdroguesdangereuses-eng.php

  The passage of Bill C-17 ("Vanessa's Law" or "Protecting Canadians from Unsafe Drugs Act") was announced by Health Canada in November. The new legislation introduces important safety improvements and transparency measures to Canada's Food and Drugs Act, strengthening the regulation of therapeutic products, improving adverse event reporting, and allowing Health Canada to act quickly when a serious health risk is identified.  "Vanessa's Law," will affect Canadian clinical trial requirements.  The changes include a mandatory clinical trial registration initiative to ensure public disclosure of information by sponsors concerning clinical trials, and the disclosure of summary results.

• NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Launches ClinRegs Website on International Clinical Research Regulations

  The National Institute of Allergy and Infectious Diseases (NIAID) has launched ClinRegs, a website designed to help the research community explore clinical research regulations within specific countries and compare regulatory requirements across countries.

  To access ClinRegs, go to clinregs.niaid.nih.gov.

• FDA Draft Guidance: Informed Consent Information

  The FDA has issued a draft guidance on Informed Consent. This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA's informed consent regulations. This guidance, when finalized, will supersede "A Guide to Informed Consent," issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. Read more...

• SOCRA programs meet industry criteria for ICH GCP investigator site personnel training

  Clinical researchers who hold the SOCRA “CCRP,” Certified Clinical Research Professional designation, as well as those clinical researchers who complete specific SOCRA GCP courses, meet the minimum criteria for ICH GCP investigator site personnel training as identified by TransCelerate BioPharma member companies.

   

   

   
• New Guidance: Electronic Source Data in Clinical Investigations

  This guidance addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol. The guidance discusses the following topics related to electronic source data:

  • Identification and specification of authorized source data originators
  • Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
  • Ways to capture source data into the eCRF using either manual or electronic methods
  • Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
  • Use and description of computerized systems in clinical investigations

   Read More

• Revised FDA Compliance Program Guidance Manual

  We feel that you should be advised that FDA has issued (March 11, 2011) a revised Compliance Program Guidance Manual (CPGM) for FDA Staff, for inspections of Sponsors, Contract Research Organizations and Monitors (CP 7348.810). By reading this guidance, you will understand exactly what the FDA investigator will be seeking to verify. The guidance will help you to assure that your own practices, policies and procedures address all of the areas noted in Part 3 – Inspectional. Part 3 involves evaluation of the sponsor’s/CRO’s/monitor’s practices and procedures in order for FDA Investigators to determine compliance with applicable regulations.

  SoCRA’s Clinical Research conferences and workshops all address the regulations, guidance and practices involved in clinical trials through lecture, case studies, and discussion.

  SoCRA Annual Conference
  FDA Clinical Trial Requirements
  Site Management Workshops
  Clinical Research Monitoring Workshops
  Clinical Investigator Conference

• AAHRPP’s Standard I.7.A.

  Click Here for AAHRPP’s clarification of their Standard I.7.A. pertaining to IRB approval of protocols for Phase 1 trials, specifically the issue of whether an IRB can approve advertising, recruiting, and screening procedures to begin prior to the end of the 30-day FDA review period or prior notification from FDA.

• AAHRPP, The Association for the Accreditation of Human Research Protection Programs, announced on March 20, that it has accredited four more organizations.

  AAHRPP, The Association for the Accreditation of Human Research Protection Programs, announced on March 20, that it has accredited four more organizations.

  King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia

  National Institutes of Health, Bethesda, Md. - The AAHRPP accreditation covers the NIH intramural research program, including NIH investigators at more than 20 institutes and centers on all NIH campuses.

  St. Jude Children’s Research Hospital, Memphis, Tenn.

  Taipei Medical University Hospital, Taipei, Taiwan

  AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government. To learn more, visit www.aahrpp.org.

• FDA Requires New Informed Consent Elements

  The Food and Drug Administration (FDA) is amending the current informed consent regulations (21 CFR Part 50) to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

   

  This rule is effective March 7, 2011. The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date. See section III of the document for an additional explanation of the compliance date and required implementation of this final rule. See Federal Register: Informed Consent Elements for all details relating to this final rule.