Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 14 Issue 1 - Page 3 - Spring 2011
SPONSORS AND REVIEW OF REPORTS |
Perhaps the biggest controversy today involves the Sponsor’s role in review and comment on final reports. Although the GLPs do not address such, Sponsors have been reviewing and commenting on reports since the inception of GLPs. In most cases, comments simply involve clarification and request for additional detail, although occasionally Sponsors have asked for unfavorable results to be “softened”. In todays environment Sponsors can add very valuable information that might not be readily apparent to the Study Director, largely due to their in-depth knowledge of their compound and prior studies. A recent warning letter stated that if CROs send draft reports along with draft contributor reports to the Sponsor, the Sponsor may unduly bias the data.
“Furthermore, given that Study Directors invite the study sponsors to comment on and edit both the contributing scientist reports and the final report, bias in data interpretation and reporting cannot be ruled out.”
I do not think that FDA’s intent is to suppress Sponsor involvement, but to rather make such involvement transparent. When CROs send drafts to Sponsors for comments, all comments and suggested changes from the Sponsor should be maintained in the archives along with the draft and final reports. This is not unlike the FDA requirement for Sponsors submitting Interim reports. When a Sponsor submits an Interim report, it must be finalized within a set time period and the Sponsor is required to clearly identify all items that have been changed from Interim to final. It is not unreasonable for FDA to expect that the same procedure be applied to draft reports sent to Sponsors.
To cite the GLPs for this requirement, one only has to look at the definition of raw data:
Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study.
|
WCQTI provides a practical, scientific approach to Good Laboratory Practice Regulations, focusing on industry standards and common sense as well as the written code. Training materials are over 1400 pages (now on a handy CD!) and include numerous forms, SOPs, reference articles, and other material critical to interpreting the intent of the regulations. Courses are structured to be highly interactive, providing opportunities for workshops and discussions. Every effort is made to present subjects in an informative, energetic manner. Additional experts in their particular field are brought in periodically for certain courses. |
ABOUT THE DIRECTOR |
Ms. Deborah Eyer Garvin, Director of the West Coast Quality Training Institute earned her MS in Agriculture from New Mexico State University. Ms. Garvin is also President of Pacific Rim Consulting, a Quality Assurance firm specializing in consulting and auditing for FDA, EPA and OECD GLPs as well as FDA GCPs for Target Animal studies. She provides contract QA services and training to Sponsor Companies, Project Management groups, Contract Laboratories, Universities, Teaching Hospitals, and individual test sites. Coming from a contract laboratory background, Ms. Garvin has implemented GLP compliance programs at several facilities, and understands the practical aspects of GLP compliance and adherence. Constant involvement in auditing and inspecting provides unique insights regarding current problems and issues, as well as cost-effective means of compliance. Numerous professional organizations have utilized her expertise as a consultant and invited speaker. Active in the Society of Quality Assurance, Debi is a Past President of the National organization, past chair of the SQA Registration Examination Committee, and was an original member of the Professional Certification Committee. She represented the Society of Quality Assurance at the OECD workshop held in the UK regarding multi-site studies, represented the FDA at the 2008 OECD GLP Harmonization workshop, and serves on the editorial board of the QA Journal. She is also a member of the SQA FDA Modernization of GLPs task force.
Seminars offered by WCQTI
(not all seminars are offered every year, but all are offered for in-house training)
|
One Day Seminars
- GLPs 101 (an Introduction)
- GLP Essentials for Technical Staff
- SOPs 101
Two Day Seminars
- QA Audits, Inspections and Responsibilities
- GLPs in the Real World
- GLPs for Scientists and Technical Staff
- Application of GLPs to Field Studies
- GCPs/GLPs in Target Animal Studies
- GLPs in Medical Devices
- Application of GLPs in the Bioanalytical Lab
- GLPs for Study Directors and Monitors
ON SITE TRAININGAny seminar or combination of seminars can be customized to meet your company’s needs, and provided on site or at your choice of venues. Fees are invoiced at a flat rate with no “add-ons” or “per-person” charge. Call Debi at (541) 352-7120 for more information or email debi@pacrimqa.com |