Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 14 December 2016 | By Zachary Brennan
The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products.
The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure protection of the rights, safety and welfare of human subjects; facilitate the subject’s comprehension of the information presented; ensure appropriate documentation is obtained when multiple electronic media are used; and ensure the quality and integrity of eIC data included in FDA applications and made available to the agency during inspections.
In terms of changes to the draft, first issued in March 2015, FDA notes that there’s further clarification in all 16 questions and answers, including those on how to present information in the eIC to the subject, steps to improve the subject’s understanding of the research, how to verify a subject’s identity who electronically signs the informed consent, how to use eIC for pediatric studies, what eIC documentation is required for FDA submissions, steps to ensure that eIC materials are archived appropriately and what eIC documents FDA will require during an inspection.
The sponsor of FDA-regulated research is expected to submit to the agency “the same eIC materials that will be presented to subjects to obtain eIC for their participation in the clinical investigation.”
And although investigational new drug application (IND) regulations do not specifically require submission of informed consent documents to FDA as part of an IND, the Q&A notes that the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) may request submission of the informed consent form for review under certain circumstances, for example, “when unusual known clinical toxicity is associated with the study drug or class of drugs; when the study population is particularly vulnerable; when the clinical investigation has significant potential for serious risks to human subjects; or for a postmarket safety clinical trial.”
However, on the medical device side, the guidance notes that investigational device exemption (IDE) regulations do require such applications to include copies of all forms and informational materials provided to subjects for obtaining informed consent.
As far as site inspections, the guidance notes: “FDA regulations require that FDA be granted access to records and reports made by the investigator, including site-specific versions of the eIC, the materials submitted to IRBs for review and approval, all amendments to the site-specific eICs, and all subject-specific signed eICs,” the final guidance says.
Use of Electronic Informed Consent Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors
Tags: electronic informed consent, eIC, medical research and informed consent, informed consent and FDA guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.