Online Safety Community

Clinical Data Management - Benefits of Standardization in Establishing CDM Processes

Event Details

Clinical Data Management - Benefits of Standardization in Establishing CDM Processes

Time: May 17, 2018 at 9am to May 18, 2018 at 6pm
Location: Philadelphia, PA
Street: Philadelphia, PA
City/Town: Philadelphia, PA
Website or Map: https://www.globalcompliancep…
Phone: 8004479407
Event Type: seminar
Organized By: John Robinson
Latest Activity: Mar 22

Export to Outlook or iCal (.ics)

Event Description

When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.

This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring.

  • A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; this ensures that data are well-managed in the present, and prepared for preservation in the future.
  • Study startup activities include designing case report forms (CRFs), paper or computer; specifying cleaning rules (edit checks); building and testing the database; and releasing the study database to collect data.
  • Study conduct activities include collecting the data on CRFs and via electronic files, cleaning that data, managing adverse event and serious adverse event collection, and producing reports.
  • Study closeout focuses on ensuring the data is complete and of a quality to support final analysis.
  • Study monitoring is an in-person evaluation carried out by sponsor personnel or representatives at the sites at which the clinical investigation is being conducted. On-site monitoring can identify data entry errors (e.g., discrepancies between source records and case report forms (CRFs)) and missing data in source records or CRFs; and assess compliance with the protocol and investigational product

Link: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901738SEMINAR

Comment Wall

Comment

RSVP for Clinical Data Management - Benefits of Standardization in Establishing CDM Processes to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
15 hours ago
Adam Fleaming posted a blog post

Simple but [Important Things] to Remember About FDA Trainings

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of ensuring safety and reliability of the products.This…See More
15 hours ago
Training Doyens posted events
17 hours ago
John Robinson posted events
Friday

Forum

Safety - A Prerequisite 12 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Jen McDade 18 hours ago.

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service