Standard Digital Signatures and How They Can Enhance Clinical Operations
Original Air Date: October 5, 2011
Expiration Date: October 5, 2012
Contact Hours: Earn 1.5 ACRP or CBRN contact hours
Level: Intermediate
Cost: $119 Regular Rate; $79 Member Rate
Try Before You Buy
Objective of This Webinar
From this session, participants will gain an understanding on how standard digital signatures can enhance clinical operations. The discussion will address the most common applications where this technology is being used:
- Quality Management Systems (QMS) - and electronic document management (EDM) systems for signing documents that are used to support FDA audits for GxP compliance. These documents include SOPs, work instructions, training records and project/task documentation. The use of digital signatures tightly integrated with an EDM (such as SharePoint®, Documentum©, OpenText, Oracle®, etc.) will be addressed, as will digital signature use for companies that do not have an EDM system in place.
- Site Visit Monitoring Reports - automating the process of signing trip reports and submitting to the study sponsor within 10 business days, including the signing of Microsoft® Word and PDF templates and reports generated from clinical trial management systems (CTMS).
- eClinical Portals – investigator portals and electronic trial master file (eTMF) applications where site/IRB personnel can digitally sign FDA regulatory packet documents in order for the site to be initiated, as well as other ongoing site documentation such as mid-study updates, adverse event safety letters, and site closeouts. This topic will also include a description of easy-to-use (sign) solutions that have been successful in gaining end-user adoption and acceptance.
Each of these clinical applications will be described from the perspective of CROs, sponsors, site personnel, and regulatory authorities that may be signers and/or recipients of signed documents that need to be validated and trusted. Case studies will be presented for deployments at top 10 BioPharmas, CROs and software/service (SaaS) vendors offering QMS/EDM, eTMF/investigator portals, and CMTS solutions.
Participants will receive a quick immersion into the digital signatures standard and what impact it has on source document retention policies, trust by external parties in secure document exchange, and comparison to proprietary electronic signatures.
What You Will Learn:
Upon completion of this webinar, attendees should be able to:
- Describe the potential value gained by replacing paper processes with electronic processes with digital signatures.
- Explain the digital signature standard and how this differs from other forms of proprietary electronic signatures.
- Identify the most common applications where digital signatures are being used in GCP operations.
Who Will Benefit
This webinar is intended for Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Clinical Research Administrators, Pharmacovigilance Monitors, Principal Investigators, Project Directors and Project Managers working for Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and Site Management Organizations (SMOs).
Meet your Presenter
Rodd Schlerf is the Life Science Practice Manager for ARX and is responsible for the strategy and delivery of CoSign digital signature product into the global FDA regulated markets.
Disclosure Statements
Mr. Schlerf states that he is an employee of ARX, a digital signature vendor.
Program Numbers
Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2011-REP-319).
Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form. These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2011-REP-319).
Continuing education credits/contact hours are awarded with the completion of an online evaluation form, which must be completed prior to the product’s expiration date. Upon submission of the evaluation form, a link to the printable certificate will be made available on the attendee’s My Tests, Evaluations & Certificates page.