|
|
| Monitoring Techniques for Electronic Records & GCP Compliance Update |
|
|
| Learn to manage the additional challenges of monitoring and auditing computerized source documents. The advanced monitoring techniques presented will be reinforced through your participation in the interactive workshops. Part 11 requirements such as electronic records and signatures are discussed in addition to the issues related to Part 11 non-compliance. In the GCP Compliance Update, topics will be presented to inform you of the current inspectional focus and you will learn how to deal with current and/or emerging regulatory and clinical issues |
|
| Monitoring Techniques for Electronic Records |
|
| AGENDA |
|
| 7:30 |
am |
- |
8:30 |
am |
Continental Breakfast |
|
|
| 8:30 |
am |
- |
9:00 |
am |
Overview of Part 11 Requirements |
| 9:00 |
am |
- |
10:30 |
am |
Monitoring Computerized Source Documents |
|
|
|
|
|
- Prequalification |
|
|
|
|
|
- Electronic Signature |
|
|
|
|
|
- Electronic Data Collection Tools |
| 10:30 |
am |
- |
10:45 |
am |
Break |
| 10:45 |
am |
- |
11:15 |
am |
Workshop: Managing Non-compliance with Part 11 at Clinical Sites |
| 11:15 |
am |
- |
12:15 |
pm |
E-Monitoring Workshop |
| 12:15 |
pm |
- |
1:15 |
pm |
Lunch |
|
| GCP Compliance Update |
|
| AGENDA |
|
| 1:15 |
pm |
- |
2:00 |
pm |
GCP Regulatory Update |
|
|
|
|
|
- Impact of Proposed Regulations |
|
|
|
|
|
- Current Inspectional Focus |
|
|
|
|
|
- Discussion of Recent FDA 483s, Warning Letters |
|
|
|
|
|
- Recent FDA Activities |
| 2:00 |
pm |
- |
2:45 |
pm |
Investigator's Responsibilities and Delegation of Authority |
| 2:45 |
pm |
- |
3:15 |
pm |
Ethics and HIPAA |
| 3:15 |
pm |
- |
3:30 |
pm |
Break |
| 3:30 |
pm |
- |
4:00 |
pm |
Responding to Issues of Non-Compliance |
| 4:00 |
pm |
- |
4:45 |
pm |
Dealing with Difficult Issues |
|
|
|
|
|
- Maintaining Patient Confidentiality |
|
|
|
|
|
- SMOs |
|
|
|
|
|
- Delegation of Authority |
|
|
|
|
|
- Electronic Records |
| 4:45 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Prevention and Detection of Scientific Misconduct and Fraud |
|
|
|
| You will learn new techniques to review clinical site records and identify signs of fraudulent data . Techniques and tools are taught and interactive workshops are conducted to teach you skills of identifying "The Top 10 Red Flags of Fraud" and/or misconduct. You will learn how to assure the reliability of the data that is submitted in NDA applications. |
|
| AGENDA |
|
| 7:30 |
am |
- |
8:30 |
am |
Continental Breakfast |
| 8:30 |
am |
- |
9:00 |
am |
Overview of Sponsor's Obligations |
| 9:00 |
am |
- |
10:30 |
am |
"Auditor" Techniques and Tools |
| 10:30 |
am |
- |
10:45 |
am |
Break |
| 10:45 |
am |
- |
11:15 |
am |
Trend Analysis of Data |
| 11:15 |
am |
- |
12:15 |
pm |
Workshop: Fraud Cases |
| 12:15 |
pm |
- |
1:15 |
pm |
Lunch |
| 1:15 |
pm |
- |
2:30 |
pm |
Workshop: Handling Internal Fraud |
| 2:30 |
pm |
- |
3:30 |
pm |
Workshop: Fraud - "What are the top ten red Flags?" |
| 3:30 |
pm |
- |
3:45 |
pm |
Break |
| 3:45 |
pm |
- |
4:15 |
pm |
Internal Procedures for Handling Potential Scientific Misconduct and Fraud |
| 4:15 |
pm |
- |
4:45 |
pm |
Potential Consequences for All Parties |
| 4:45 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Advanced Prevention and Detection of Scientific Misconduct and Fraud |
|
|
| This course was developed to build on the skills learned in the Basic Prevention and Detection of Scientific Misconduct and Fraud Course and is also designed for experienced clinical research professionals who want to learn advanced techniques for managing scientific misconduct. Attendees will analyze recent cases of fraud and learn how to avoid potential problems by using advanced interviewing techniques. Monitors will learn how to optimize their site selection process and will learn how to develop a fraud resistant environment at a clinical site. |
|
| AGENDA |
|
| 7:30 |
am |
- |
8:30 |
am |
Continental Breakfast |
| 8:30 |
am |
- |
9:00 |
am |
Overview of Misconduct vs Fraud |
| 9:00 |
am |
- |
10:30 |
am |
Investigative Techniques |
| 10:30 |
am |
- |
10:45 |
am |
Break |
| 10:45 |
am |
- |
11:15 |
am |
Optimizing Site Selection |
| 11:15 |
am |
- |
12:15 |
pm |
Workshop: NIDPOE Letter Fraud Cases |
| 12:15 |
pm |
- |
1:15 |
pm |
Lunch |
| 1:15 |
pm |
- |
2:30 |
pm |
Developing Fraud Resistant Sites |
| 2:30 |
pm |
- |
3:30 |
pm |
Workshop: Assuring good data when submitting data from an Investigator-held IND |
| 3:30 |
pm |
- |
3:45 |
pm |
Break |
| 3:45 |
pm |
- |
4:15 |
pm |
Responding to Issues of Non-compliance |
| 4:15 |
pm |
- |
4:45 |
pm |
Potential Ramifications of submission of faulty data |
| 4:45 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Preparing for an FDA Inspection |
|
|
| Learn the steps you need to prepare for an FDA Inspection of a sponsor or a clinical site. The development of a standard operating procedure for inspections, including the training of staff who participate in an inspection, and the actual management of the inspection process are all discussed in detail. Interactive workshops and practical experience will be used to demonstrate the elements of preparation you need to assure a successful inspection. |
|
| AGENDA |
|
| 7:30 |
am |
- |
8:30 |
am |
Continental Breakfast |
| 8:30 |
am |
- |
9:00 |
am |
Introduction |
| 9:00 |
am |
- |
10:00 |
am |
Overview of the FDA Inspection Process |
| 10:00 |
am |
- |
10:15 |
am |
Break |
| 10:15 |
am |
- |
11:00 |
am |
How to Prepare for the FDA Inspection |
| 11:00 |
am |
- |
12:00 |
pm |
Workshop: "FDA is on their way!" |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
1:30 |
pm |
Overview of the Regulatory Responsibilities |
| 1:30 |
pm |
- |
2:30 |
pm |
FDA Compliance Programs for Inspection |
| 2:30 |
pm |
- |
2:45 |
pm |
Break |
| 2:45 |
pm |
- |
3:45 |
pm |
Workshop: Analysis of the FDA 483 - List of Observations |
| 3:45 |
pm |
- |
4:30 |
pm |
Inspection Follow-up by FDA, by the Investigator & by the Sponsor |
| 4:30 |
pm |
- |
5:00 |
pm |
Q & A |
|
|
| Advanced Monitoring Series |
|
| Optimizing the CRA's Role |
|
|
| You will enhance your skills and create a plan to optimize the monitoring process. As an experienced monitor, you will participate in interactive workshops and exercises that will focus on building relationships, fostering collaboration, refining prioritizing skills, and learning how to handle and reverse the course of a "problem site". |
|
| AGENDA |
|
| 8:00 |
am |
- |
9:00 |
am |
Introduction & Attendee's Expectations |
| 9:00 |
am |
- |
9:30 |
am |
Icebreaker: What Makes an Expert in Clinical Research? |
| 9:30 |
am |
- |
10:15 |
am |
Plan: Using all Available Tools |
| 10:15 |
am |
- |
10:30 |
am |
Break |
| 10:30 |
am |
- |
12:00 |
pm |
Learn: Building the Information Base |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
2:15 |
pm |
Act: Selective Neglect vs. Prioritizing |
| 2:15 |
pm |
- |
2:30 |
pm |
Break |
| 2:30 |
pm |
- |
3:15 |
pm |
Negotiate: Building Relationships |
| 3:15 |
pm |
- |
3:45 |
pm |
Securing: Reinforcing/Maintaining the Skills |
|
|
|
|
|
- Therapeutic expertise |
|
|
|
|
|
- Regulatory knowledge |
|
|
|
|
|
- Developing relationships |
| 3:45 |
pm |
- |
4:30 |
pm |
Workshop: Turning Around a Problem Site |
| 4:30 |
pm |
- |
5:00 |
pm |
Q & A for Real-life Situations |
|
| Preparing Effective Monitoring Reports |
|
|
| Monitoring reports are the essential documentation of monitoring activities, so it is imperative that you know exactly what to include and how to present the facts effectively. You will learn to develop a formula to create accurate, concise and informative monitoring reports that will be effective for site management. You will participate in an interactive workshop to create and critique monitoring reports and discover the areas of FDA focus on monitoring reports during an inspection. |
|
| AGENDA |
|
| 8:00 |
am |
- |
8:30 |
am |
Introduction & Attendee's Expectations |
| 8:30 |
am |
- |
8:45 |
am |
Mini Workshop/Icebreaker |
| 8:45 |
am |
- |
9:15 |
am |
Regulatory Requirements for Monitoring Reports |
| 9:15 |
am |
- |
10:00 |
am |
Formula for a Good Monitoring Report - Interactive session |
|
|
|
|
|
Pre-Study, Initiation, Interim, Close-out |
| 10:00 |
am |
- |
10:15 |
am |
Break |
| 10:15 |
am |
- |
11:00 |
am |
Writing for Impact |
| 11:00 |
am |
- |
12:00 |
pm |
Workshop |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
2:00 |
pm |
What do I Include and How do I Write it? |
| 2:00 |
pm |
- |
3:00 |
pm |
Workshop: Writing an Effective Monitoring Visit Report |
| 3:00 |
pm |
- |
3:15 |
pm |
Break |
| 3:15 |
pm |
- |
4:00 |
pm |
Workshop: Part II (Peer Review) |
| 4:00 |
pm |
- |
4:30 |
pm |
What FDA Looks for in a Monitoring Visit Report |
| 4:30 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Advanced Auditing Series |
|
| Pre-Qualification Audits of CROs |
|
|
| This interactive workshop will focus on the skills necessary to evaluate the capabilities of CROs before they begin work for your company. Attendees will analyze recent FDA inspections and learn how to detect potential problems. Monitors and auditors will learn how to optimize their CRO selection process and will learn how to minimize potential issues that occur when monitoring is contracted to a third party. |
| An Interactive Workshop |
|
| AGENDA |
|
| 7:30 |
am |
- |
8:30 |
am |
Continental Breakfast |
| 8:30 |
am |
- |
9:00 |
am |
Overview of Pre-Qualification Audits |
| 9:00 |
am |
- |
9:30 |
am |
Review of Regulation & Types of CROs Defined |
| 9:30 |
am |
- |
10:30 |
am |
Optimizing CRO Selection |
| 10:30 |
am |
- |
10:45 |
am |
Break |
| 10:45 |
am |
- |
11:30 |
am |
Assessment Techniques |
| 11:30 |
am |
- |
12:30 |
am |
Workshop: Planning a CRO Audit |
| 12:30 |
pm |
- |
1:30 |
pm |
Lunch |
| 1:30 |
pm |
- |
2:30 |
pm |
Conducting a CRO Audit |
| 2:30 |
pm |
- |
3:30 |
pm |
Reviewing CRO's SOPs |
| 3:30 |
pm |
- |
3:45 |
pm |
Break |
| 3:45 |
pm |
- |
4:15 |
pm |
Workshop: Managing Non-compliance Issues |
| 4:15 |
pm |
- |
4:45 |
pm |
Potential Ramifications of CRO Problems |
| 4:45 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Auditing Institutional Review Boards (IRBs) |
|
|
| You will learn the regulations governing IRBs and methods used to assess regulatory compliance. This workshop will provide you with the knowledge, skills, tools and proper techniques required to plan and conduct audits of IRBs. The critical points of an FDA inspection and managing the findings of IRB audits are covered for you in complete detail. |
|
| AGENDA |
|
| 8:00 |
am |
- |
8:30 |
am |
Introduction & Attendee's Expectations |
| 8:30 |
am |
- |
9:15 |
am |
History of IRBs |
| 9:15 |
am |
- |
9:30 |
am |
Workshop: What Do You Know about IRBs? |
| 9:30 |
am |
- |
10:15 |
am |
IRB Regulations |
|
|
|
|
|
* FDA |
|
|
|
|
|
* DHHS |
|
|
|
|
|
* OHRP |
| 10:15 |
am |
- |
10:30 |
am |
Break |
| 10:30 |
am |
- |
11:00 |
am |
IRB Membership Qualifications |
| 11:00 |
am |
- |
11:30 |
am |
IRB SOP Requirements |
| 11:30 |
am |
- |
12:00 |
pm |
Self Assessment Checklist for IRBs |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
1:45 |
pm |
FDA Inspection Process at IRBs: CP7348.809 |
| 1:45 |
pm |
- |
2:30 |
pm |
Workshop: IRB Inspections (OHRP and FDA) |
| 2:30 |
pm |
- |
3:15 |
pm |
Audit Planning: "When Should an IRB be Audited? |
| 3:15 |
pm |
- |
3:30 |
pm |
Break |
| 3:30 |
pm |
- |
4:15 |
pm |
Workshop: Managing the Audit Findings |
| 4:15 |
pm |
- |
4:30 |
pm |
Workshop: Wrap-up |
| 4:30 |
pm |
- |
5:00 |
pm |
Q & A |
|
| Preparing Effective Audit Reports |
|
|
| To encourage management to take corrective action, you need to present problems in a clear, concise and effective manner. This hands-on workshop helps you form the special skills required to create a strategically targeted report to grab management's attention. Using methods you will learn to consolidate your findings for impact, you will prepare an actual audit report highlighting systemic problems that require corrective action and will learn to avoid "nit-picking" which can dilute the effectiveness of your report. |
|
| AGENDA |
|
| 8:00 |
am |
- |
8:30 |
am |
Introduction & Attendee's Expectations |
| 8:30 |
am |
- |
9:00 |
am |
Icebreaker |
| 9:00 |
am |
- |
10:00 |
am |
Creative Writing vs. Audit Reports |
| 10:00 |
am |
- |
10:15 |
am |
Break |
| 10:15 |
am |
- |
11:00 |
am |
Workshop: Clarifying Findings |
| 11:00 |
am |
- |
12:00 |
pm |
Organizing and Consolidating Findings for Impact |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
2:00 |
pm |
Workshop: Preparing to Write |
| 2:00 |
pm |
- |
3:00 |
pm |
Workshop: Writing an Effective Audit Report |
| 3:00 |
pm |
- |
3:15 |
pm |
Break |
| 3:15 |
pm |
- |
4:15 |
pm |
Workshop (Continued): Peer Review |
| 4:15 |
pm |
- |
4:45 |
pm |
Workshop (Continued): Wrap-up |
| 4:45 |
pm |
- |
5:00 |
pm |
Q & A |
|
|
| Providing GCP Training to Clinical Site Staff |
|
|
| Attendees will learn how to ensure that clinical site staff are available and receptive to sponsor-provided training, which is the first step to successful training. Course instruction will focus on the tools that are necessary for adequately assessing staff GCP knowledge, as well as, appropriate training materials that enable the trainer to target the needs of the clinical site staff. Finally, you will learn how to assess clinical site staff training by understanding the requirements in a GCP Training Program and by participating in a "hands-on" analysis of actual GCP training documents. |
|
| AGENDA |
|
| 8:30 |
am |
- |
9:00 |
am |
Introduction & Attendee's Expectations |
| 9:00 |
am |
- |
9:30 |
am |
Isn't the Investigator's Meeting Enough? |
| 9:30 |
am |
- |
10:00 |
am |
Requirements for GCP Training of Site Staff |
| 10:00 |
am |
- |
10:30 |
am |
Workshop: Assessing GCP Training Documentation |
| 10:30 |
am |
- |
10:45 |
am |
Break |
| 10:45 |
am |
- |
11:15 |
am |
Getting Site Staff Buy-in for GCP Training |
| 11:15 |
am |
- |
12:00 |
pm |
Workshop: Designing an Agenda for Site Training |
| 12:00 |
pm |
- |
1:00 |
pm |
Lunch |
| 1:00 |
pm |
- |
1:45 |
pm |
Assessment Tools to Determine GCP Knowledge |
| 1:45 |
pm |
- |
2:30 |
pm |
Training Materials |
| 2:30 |
pm |
- |
3:00 |
pm |
How to Manage Regulatory Documents |
| 3:00 |
pm |
- |
3:15 |
pm |
Break |
| 3:15 |
pm |
- |
3:45 |
pm |
Follow-up Training |
| 3:45 |
pm |
- |
4:30 |
pm |
Workshop: Problem Analysis and Solutions |
| 4:30 |
pm |
- |
5:00 |
pm |
Q & A |
|
