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Clinical Trial Data Management and Resolution – (DMR01)

A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP

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  • To Register On-line: select the course date below, then click on Pay Now (securely processed by PayPal
  • To Register by FAX: download form (PDF)
Locations to choose from:

Contact Us :


Tel:  +954-957-3957;
Fax: +954-366-6011;

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Early registration for the RESORT is $750 +tax, if paid in full by June 28th/2010, after that is $975 + tax.
Early registration for the CRUISE is $1350 +tax, if paid in full 75 days or more before the start, after that is $1550 + tax.

***Choose SPECIAL: If you want to register for A005 (RESORT- July 29-30th/2010) and DMR01 (RESORT- July 31st and Aug 1st/2010) and pay in full by June 28th/2010,

total cost=$1500+tax for both classes (July 29th-Aug1st/2010)***

To Register On-line:

Click on the arow below, select the course date, and then click on Pay Now (securely processed by PayPal)

Clinical Trial Data Management and Resolution

Course Overview

Data is the ultimate result of a clinical trial. We must ensure data accuracy, consistency, integrity, and auditability (ICH/GCP).

Capture, verification, transfer and analysis of Clinical Trial Data are extremely critical. The clinical research investigator has to make sure that the data collected in the patient files is accurate and represents protocol requirements for the clinical study.

The process of data capture, verification, transfer and analysis may involve many steps. The manual process of capturing data, as well as transferring it to the CRF and further to the database is prone to errors and omissions. Electronic systems may involve hybrid solutions that may increase accuracy, however the investigator must be aware of the regulatory implications on having electronic systems in clinical trial processes originally established as paper based.

This course will provide the Principal Investigator with the basic knowledge of data capture in clinical research, data transfer to Case Report Forms, compliant processes for data verification, monitoring and auditing.

The investigator will also be introduced to new technologies utilized in clinical research as well as future trends.

The program

  • 21CFR312 and ICH/GCP Investigators responsibilities in clinical trials,
  • 21 CFR 11 Electronic records and signatures, implications of having electronic systems in clinical trials at the clinical trial site.
  • Delegation of responsibilities of the investigator to the clinical trial personnel
  • Clinical trial data
  • The source documents, patient files, charts, lab results and other assessments. Patient assessments and patient diaries.
  • Data Capture, manual and electronic systems
  • Data Transfer to the Case Report Form, manual and electronic systems
  • The Case Report form
    • design,
    • completion,
  • Safety data reporting (Serious Adverse Events) to IRBs and Sponsor
  • Adverse drug reaction reporting
  • Workshop I
    • Protocol assessment for data collection
    • Data collection relevant to the clinical trial in the source document
    • Design of the Case Report Form according to protocol
    • Transfer of data to the CRF
  • The investigators site data verification process
    • Sources of error in manual data entry
    • Electronic systems in data accuracy and integrity
    • Correction of errors in paper CRFs
    • Correction of errors in electronic systems
    • The audit trail
      • Paper audit trail
      • Electronic audit trail
  • Monitoring Clinical Trial Data
    • 21 CFR 312 Monitoring responsibilities for the SPONSOR/INVESTIGATOR
    • The monitoring process
    • Monitoring modalities
      • Site monitoring
      • Fax/phone/e Monitoring
      • Statistical Sampling
    • Assessment of errors
    • Safety monitoring
    • Data Safety Monitoring Boards
    • The monitoring visit
    • Monitoring findings, records
    • Follow up on monitoring findings
    • How to solve discrepancies between monitor and investigator site
  • Auditing clinical trial data
    • The audit process
    • Type of inspections
    • Data audit and findings
  • Workshop II
    • Monitoring a Case Report Form
    • Data verification
    • The monitoring report

Who Should Attend

  • Principal investigators
  • Clinical Trial Nurses
  • Sub or co investigators
  • Clinical Research Associates
  • Clinical Trial Coordinators
  • Clinical Trial Monitors

CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL

Upon Completion of the course:

  • ***CME: 12 Elective credits by the American Academy of Family Physicians will be available to qualifying participants and
  • All participants will receive a Certificate of Attendance
  • Also, after completion of the course, participant may decide to take a comprehension exam. If the exam is passed successfully, participant will receive the Certificate of Completion (step 2 of CCP Certification).

  • Registration fee for the RESORT includes:

    • 2 whole days of training in a beautiful ocean-front hotel,steps to popular Las Olas Beach, in Fort Lauderdale, Florida
    • Presentation, Reference and Study Materials( printed, also electronic copy)
    • Breakfast, Luncheon and Refreshments

    Registration fee for the CRUISE includes:

    • 2 whole days of training on a luxury Friday to Monday All-Inclusive CRUISE
    • Presentation, Reference and Study Materials( printed, also electronic copy)
    • All meals and Refreshments
    • Each participant will receive a copy of the book:

    "Good Clinical Practice (GCP) Audit Preparation: A Guide for the Pharmaceutical Industry", by: dr Mihajlovic- Madzarevic, Vera (to be published in April 2010 - ISBN: 9780470248850-Wiley)
  • Not Included
    • Airfare
    • Transportation to/from the airport
    • Parking, tips...
    • **Hotel accomodation: (Pelican Beach resort is completely non-smoking)
    To reserve your room, call Amanda Mohler at Direct - 954.556-7560, Hotel-954.568.9431 or (800) 525-OCEAN and mention the "Clinical Research Institute of America's" special rate for the room (valid up to 1 month before course starts). You may also want to send an e-mail to: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    • Tax is not included, please add 6% to the price of the course.

    Special group rates for this course (% off  the regular price of the course):

    • From 1-2 people from the same facility/clinic - as advertised
    • From 3 and up to 5 - 10% discount for the entire group
    • From 6 and up to 10 - 15% discount for the entire group
    • More than 10 people per group - please call Vesna at 1-877-428-1427

    Upon registration, you will receive a complete agenda and detailed information.

    At the time of registration, please notify us of any special dietary requirements.

    Enrolment to the course is accepted until one (1) week before the starting date.

    Clinical Research Institute of America reserves the right to cancel the course, if insufficient number of students are enrolled.

    For more information please Contact Us at:

    Phone: 1-877-428-1427 (toll free USA & Canada) or +954-975-0860 Fax: 954-366-6011

    E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

    *CANCELLATION POLICY (% fee is based on a regular price of the course)

    Cancellation from date of signing up to 30 days prior to event...........full refund

    Cancellation from 30 days to 20 days prior to event.............................10% fee

    Cancellation from 20 days to 10 days prior to event….. ……............. 20% fee, after that......... 30% fee

    Note: Tax is not included - please add 6% to the price of the course.

    PRIVACY POLICY

    Any of the information we collect from you, in this form, will be used solely for the purpose of registering for this course. We do not sell, trade or otherwise transfer to outside parties any part of your personal information.

    Course Agenda DMR01

    Day 1

    Day 2
    8:30-9:00 Registration and Breakfast Breakfast
    9:00-9:15 Welcome and Introduction
    • 21CFR312 and ICH/GCP Investigators responsibilities in clinical trials,
    • 21 CFR 11 Electronic records and signatures, implications of having electronic systems in clinical trials at the clinical trial site.
    		The investigators site data verification process (continuation)
    • Correction of errors in paper CRFs
    • Correction of errors in electronic systems
    • The audit trail
    9:15-10:30
    • Delegation of responsibilities of the investigator to the clinical trial personnel
    • Monitoring Clinical Trial Data
      • 21 CFR 312 Monitoring responsibilities
      • The monitoring process
      • Monitoring modalities
      • Assessment of errors
    10:30-10:45
    Coffee Break
    10:45-11:45
    • Clinical trial data
    • The source documents, patient files, charts, lab results and other assessments. Patient assessments and patient diaries.
    • Data Capture, manual and electronic systems
    • Safety monitoring
    • Data Safety Monitoring Boards
    • The monitoring visit
    11:45-12:30
    • Safety data reporting (Serious Adverse Events) to IRBs and Sponsor
    • Adverse drug reaction reporting
    • Monitoring findings, records
    • Follow up on monitoring findings
    • Discrepancies between monitor and investigator site
    12:30-13:30
    Lunch break
    13:30-15:00
    • Workshop I
      • Protocol assessment
      • Data collection
      • Design of the CRF
      • Transfer of data to the CRF
    • Auditing clinical trial data
      • The audit process
      • Type of inspections
      • Data audit and findings
    15:00-15:15
    Coffee break
    15:15-16:00
    • The investigators site data verification process
      • Sources of error in manual data entry
      • Electronic systems in data accuracy and integrity
    • Workshop II
      • Monitoring a Case Report Form
      • Data verification
      • The monitoring report
      • QA period
    16:00-17:00 QA period Qualifying exam*
    17:00 End day 1 End of the course

    *This exam is mandatory for participants applying to the Physician Investigator Certification Program.

     

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