Description
Why should you attend?
Understanding the potential risks and benefits to your clinical development program is essential if you plan to implement centralized monitoring as described in the recently released FDA Guidance: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, Learn how to apply risk management concepts to your evaluation of this method. Get recommendations on how you might incorporate the necessary quality control and quality assurance procedures into your current SOPs and other study documents.
Hear from two speakers and get a Free documents: Attendees will receive free document on DRAFT Guidance document by the speaker
Description of the Topic:
- Applying a risk management approach to the conduct of clinical studies
- Assess viability of remote source document verification
- Explore the role for QA in successful centralized monitoring.
In recent years FDA has been encouraging application of a risk-based or quality system approach to the conduct of clinical studies, in part because of FDA inspection findings that do not change from year to year at both a Sponsor and site level. In August 2011 FDA released a draft guidance titled "Guidance for Industry; Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring”. Among other points, the guidance discusses the concept of centralized monitoring. While centralized monitoring has never been disallowed, industry has rarely embraced it prior to the release of this guidance. The use of centralized monitoring can encompass everything from ensuring documentation is onsite and retrieval of regulatory documents, through remote source document verification. In this session we will discuss applying a risk management approach to the conduct of clinical studies. We will identify what steps to take to assist in determining whether remote source document verification is doable for a given study. We will provide suggestions on how a company can incorporate QA concepts and activities into the assessment, planning and implementation phases of such a project. We will also identify potential QA interactions that will allow the study team to determine if and when they should utilize centralized monitoring and provide tools for the participant to use in making this determination.
Who Will Benefit:
Clinical research Manager
Project managers
Clinical research Associates
Monitors,
Quality Assurance professionals
Research coordinators
Clinical investigators
Meet Your Speakers:
Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice.Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena.Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007.
Why should you attend?
Understanding the potential risks and benefits to your clinical development program is essential if you plan to implement centralized monitoring as described in the recently released FDA Guidance: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, Learn how to apply risk management concepts to your evaluation of this method. Get recommendations on how you might incorporate the necessary quality control and quality assurance procedures into your current SOPs and other study documents.
Hear from two speakers and get a Free documents: Attendees will receive free document on DRAFT Guidance document by the speaker
Description of the Topic:
- Applying a risk management approach to the conduct of clinical studies
- Assess viability of remote source document verification
- Explore the role for QA in successful centralized monitoring.
In recent years FDA has been encouraging application of a risk-based or quality system approach to the conduct of clinical studies, in part because of FDA inspection findings that do not change from year to year at both a Sponsor and site level. In August 2011 FDA released a draft guidance titled "Guidance for Industry; Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring”. Among other points, the guidance discusses the concept of centralized monitoring. While centralized monitoring has never been disallowed, industry has rarely embraced it prior to the release of this guidance. The use of centralized monitoring can encompass everything from ensuring documentation is onsite and retrieval of regulatory documents, through remote source document verification. In this session we will discuss applying a risk management approach to the conduct of clinical studies. We will identify what steps to take to assist in determining whether remote source document verification is doable for a given study. We will provide suggestions on how a company can incorporate QA concepts and activities into the assessment, planning and implementation phases of such a project. We will also identify potential QA interactions that will allow the study team to determine if and when they should utilize centralized monitoring and provide tools for the participant to use in making this determination.
Who Will Benefit:
Clinical research Manager
Project managers
Clinical research Associates
Monitors,
Quality Assurance professionals
Research coordinators
Clinical investigators
Meet Your Speakers:
Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice.Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena.Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007.
