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ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank

Course #: BI13396
February 19, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13400
February 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

Use of Notes to File in Clinical Trial Essential Documentation

Course #: BI13401
February 21, 2019 | Interactive Web Seminar
8:30 AM - 10:00 AM Eastern
$751.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13402
February 21, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Monitoring Plan Development

Course #: BI13403
February 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program

Course #: BI13384
February 21 - April 25, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings.

$1,795.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

Course #: BI13404
February 28, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

Course #: BI13372
March 1 - May 10, 2019 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class April 12.

$1,795.50

10-Week Clinical Research Associate (CRA) On-Boarding Program

Course #: BI13371
March 1 - May 10, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Friday Afternoons. No class April 12.

$1,795.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13405
March 5, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research

Course #: BI13376
March 5 - May 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Tuesday Mornings. No class April 2.

$1,795.50

Introduction to Statistics for Non-Statisticians

Course #: BI13407
March 5, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Approaches to Address Challenges in Vendor Management

Course #: BI13406
March 5, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

CRO Partnership Management

Course #: BI13408
March 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Tools for Trainers: Clinical Research Job-Aids and Checklists

Course #: BI13409
March 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

TMF/eTMF Audit Strategies

Course #: BI13413
March 8, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance

Course #: BI13414
March 8, 2019 | Interactive Web Seminar
11:30 AM - 1:30 PM Eastern
$751.50

Developing Clinical Study Budgets for Sponsors

Course #: BI13410
March 12, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Writing Clinical Study Protocols

Course #: BI13411
March 13, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

Course #: BI13412
March 14, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Course #: BI13415
March 18, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

Monitoring Reports: 10 Rules of Effective Report Writing

Course #: BI13416
March 18, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Strategies for Managing Difficult Clinical Research Sites

Course #: BI13417
March 19, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

NEW! Coaching Skills for Leaders

Course #: BI13418
March 19, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Principal Investigator Oversight and the Appropriate Delegation of Tasks

Course #: BI13419
March 19, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Building Relationships with Clinical Research Sites

Course #: BI13420
March 20, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Advanced Clinical Research Coordinator Training: Moving Your Career to the Next Level

Course #: BI13421
March 20, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for Industry

Course #: BI13551
March 20, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Electronic Informed Consent Guidance: Regulatory Updates

Course #: BI13422
March 21, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management

Course #: BI13423
March 21, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$562.50

Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance

Course #: BI13424
March 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13386
March 22 - May 24, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Friday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

30-Hour Clinical Project Management Fundamentals Certification Program

EARLY REGISTRATION
Course #: BI13383
March 22 - May 31, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Friday Afternoons. No class April 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

NEW! Strategies for Having Difficult Conversations

Course #: BI13425
March 26, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program

EARLY REGISTRATION
Course #: BI13380
March 27 - May 29, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Wednesday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

Writing the Clinical Study Report

Course #: BI13426
March 27, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management

Course #: BI13427
March 27, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week CRA & CRC Beginner Program

EARLY REGISTRATION
Course #: BI13368
March 27 - May 29, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

Risk-Based Site Monitoring

Course #: BI13428
March 28, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

The Revised HHS Common Rule: What You Need to Know Now

Course #: BI13543
March 28, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50
$751.50

NEW! Strategies for Active Listening

Course #: BI13430
April 2, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites

Course #: BI13431
April 3, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Course #: BI13433
April 4, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Ensuring Success Through Smarter Site Selection and Study Feasibility

Course #: BI13432
April 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

eTMF Quality Oversight: A Risk-Based Approach

Course #: BI13434
April 5, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

Course #: BI13435
April 8, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

Course #: BI13436
April 8, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Introduction to Clinical Research

Course #: BI13438
April 9, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13437
April 9, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Understanding the FDA/OHRP Joint Guidance on Minutes of IRB Meetings

Course #: BI13439
April 9, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

Informed Consent Procedure: Lessons Learned from Inspection Findings

Course #: BI13440
April 23, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program

EARLY REGISTRATION
Course #: BI13539
April 9 - June 11, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Tuesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 8, 2019, costs are $1795.50.
$1,615.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Course #: BI13443
April 10, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Medical Writing Fundamentals: How to Write Regulatory Documents

Course #: BI13444
April 10, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Introduction to Data Management

Course #: BI13441
April 10, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50
$751.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13445
April 11, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Good Clinical Practice: Practical Application and Implementation

Course #: BI13446
April 11, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program

EARLY REGISTRATION
Course #: BI13379
April 11 - June 13, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 8, 2019, costs are $1795.50.
$1,615.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

Course #: BI13447
April 12, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Data Quality in Clinical Trials: Rationale and Impact

Course #: BI13448
April 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately

Course #: BI13449
April 17, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$562.50

Protocol Deviations: Documenting, Managing, and Reporting

Course #: BI13450
April 18, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Monitoring Oncology Clinical Trials

Course #: BI13451
April 18, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

Course #: BI13452
April 22, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

NEW! Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation

Course #: BI13559
April 23, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series

EARLY REGISTRATION
Course #: BI13374
April 23 - June 25, 2019 | Interactive Web Seminar
10:30 AM - 12:30 PM Eastern

Tuesday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 22, 2019, costs are $1795.50.
$1,615.50

NEW! Incorporating Denials Management into Clinical Research Billing

Course #: BI13453
April 23, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Case Report Form Design, Strategy, and Standards

Course #: BI13454
April 24, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Negotiation Skills for Clinical Research Professionals

Course #: BI13455
April 25, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Strategies for Building High-Performing Clinical Research Teams

Course #: BI13456
April 25, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

NEW! Auditing Techniques: A Problem-Solving Practicum

Course #: BI13554
April 29, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

Risk-Based Auditing: Effective Compliance Strategies

Course #: BI13457
April 29, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Monitoring Medical Device Trials: An Introduction

Course #: BI13458
April 29, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

NEW! Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs

Course #: BI13555
April 30, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

Course #: BI13459
April 30, 2019 | Interactive Web Seminar
11:00 AM - 1:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

Course #: BI13460
April 30, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Monitoring Visit Reports for Medical Device Studies

Course #: BI13461
April 30, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Regulatory Intelligence

Course #: BI13462
May 1, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Course #: BI13463
May 1, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

CAP and CLIA Requirements for Clinical Research Laboratories

Course #: BI13464
May 1, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13385
May 2 - July 18, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Thursday Mornings. No class July 4, July 11.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 29, 2019, costs are $1795.50.
$1,615.50

Investigational Product Accountability Best Practices

Course #: BI13465
May 2, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

Course #: BI13466
May 2, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$562.50

Current FDA and EMA Inspection Findings: Lessons Learned

Course #: BI13467
May 2, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

Course #: BI13468
May 2, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$751.50

Root Cause Analysis: Applying the Concept for Better Study Compliance Management

Course #: BI13469
May 3, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$562.50

10-Week CRA & CRC Beginner Program

EARLY REGISTRATION
Course #: BI13562
May 6 - July 22, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class July 1, July 8.


Take advantage of our $1615.50 price by registering early!
* After Friday, April 5, 2019, costs are $1795.50.
$1,615.50

NEW! Clinical Research Financial Management for Investigative Sites

Course #: BI13557
May 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Centralized TMF Management: The CRO Sponsor Partnership

Course #: BI13470
May 7, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Good Laboratory Practice for Non-Clinical Studies

Course #: BI13564
May 7-9, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Day 1: May 7, 2019 (1:00 - 3:00 p.m. Eastern); Day 2: May 9, 2019 (1:00 - 3:00 p.m. Eastern)

$940.50

eTMF Implementation Strategies

Course #: BI13471
May 7, 2019 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$751.50

Data Management Plan Creation: Content and Rationale

Course #: BI13472
May 8, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The Fundamentals of Clinical Research Project Management

Course #: BI13473
May 9, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

Trial Master Files: Why They Are Important and How to Organize Them Workshop

EARLY REGISTRATION
Course #: BI13474
May 10, 2019 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern

Take advantage of our $765.000 price by registering early!
* After Friday, April 12, 2019, costs are $945.000.
$765.00

ABCs of GCP and the 13 Principles of ICH GCP E6

Course #: BI13475
May 10, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

ABCs of Clinical Research for Clinical Administrative Support Staff

Course #: BI13476
May 10, 2019 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$751.50

Sponsor Management of Investigator Non-Compliance

Course #: BI13477
May 13, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate?

Course #: BI13478
May 13, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50