Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
Laboratory Inspection and Auditing
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations ...
Implementing UDI (Unique Device Identification) - Plan Now for Success
REACH and RoHS Compliance: Gain a Deeper Understanding
Ensuring Compliance with Advertising and Promotional Requirements ...
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach ...
21 CFR Part 11 Compliance for SaaS/Cloud Applications
Regulatory Compliance for Dietary Supplements in the US ...
Quality and GMP Compliance for Virtual Companies ...
Latin America - Understanding Regulatory Compliance ...
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
- By: Staff Editor
- Date: January 27, 2017
- Source: http://www.fda.gov
FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
The conduct of clinical trials are monitored through variety of approaches that differ between businesses, government organization, and educational institutions. Considering this variability, the FDA guidance describes the risk based strategy for monitoring, including the use of on-site monitoring, centralized monitoring, and additional alternative monitoring techniques
The alternative monitoring practices include communication with the Clinical Investigator (CI) and study site staff; review of the study site’s processes, procedures, and records including informed consent; and verification of the data accuracy submitted to the sponsor.
Risk Based Monitoring
The FDA guidance recommends the use of monitoring plan that is tailored to the specific study subject protection and data integrity risks of the clinical trial. The risk based monitoring plan should consist of the following steps:
Identification of critical data and processes to be monitored:
Examples of the type of data and processes include verification of informed consent form, documentation of processes related to study endpoints, protocol-required safety assessment and reporting serious adverse events etc.
Performing a risk assessment:
There are many risk assessment tools that can be applied to clinical trials. This guidance doesn’t specify the particular methodologies for performing the risk assessment.
Factors to consider when developing a monitoring plan:
Complexity of the study design, types of study endpoints, clinical complexity of the study population, electronic data capture, and quantity of data are some of the factors among others that should be considered when developing a monitoring plan.
Developing a monitoring plan:
The components of monitoring plan include description of monitoring approaches, communication of monitoring results, management of noncompliance, ensuring quality monitoring and monitoring plan amendments.
Though the guidance mainly focusses on monitoring the conduct of clinical trials, it also highlights additional strategies that can affect study quality.
Related Training:
Risk-based Approach to the Process of Monitoring and Auditing Clinical Trial
Data Monitoring Committees (DMCs) in Clinical Research

Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
