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Pharmaceutical company staff frequently have questions about the QA/QC process at DCR, as well as our procedures for monitoring medical safety. DCR takes pride in being able to provide timely, reputable results while treating study participants with respect and care for their well-being.
Research participants receive careful evaluation and ongoing medical monitoring through their study participation. Every study participant receives a questionnaire at the end of their study participation to enable him or her to give DCR staff feedback anonymously. Prior study participants consistently report having been very satisfied with their study participation.
DCR has consistently been praised by monitors for CRF and source document quality. Our Study Coordinators are all certified by the Academy of Clinical Research Professionals. Each Coordinator has received extensive training in Good Clinical Practices, the Informed Consent Process, the Protection of Human Research Subjects, as well as laboratory training in phlebotomy, ECG administration and IATA regulations. We work closely with monitors to learn better ways to record information. We develop study-specific source documentation for extra progress notes and phone screens.
Medical Safety QA -- All incoming lab reports and ECG's are first viewed by a study coordinator and then signed and reviewed daily by a physician sub-investigator or PI. Vital signs are monitored at every patient visit. This includes blood pressure, pulse, temperature and weight. DCR study coordinators take turns carrying a pager to give study participants 24-hour medical assistance if needed.
ICF Review -- Two copies of each signed ICF are made at a patient's screening visit. One is given to the patient. The other is given to the PI for internal verification.
CRF - QA -- There is a primary coordinator for each study. Although all coordinators perform patient visits in all studies, the primary coordinator does the data entry. This provides another level of internal QA analysis of data. The same coordinator does not perform the study visit and the data entry.
Source Document Quality -- DCR generates fresh source documents for each new study. The source documents are tailored to match the CRF forms for each study and each visit. Study monitors are also encouraged to offer suggestions or updates to make the source documents as useful and accurate as possible.
"Dr. DuPont,
I am writing this letter to you in response to the Corporate Quality Assurance (CQA) audit that was performed at your site on January 29th and 30th, 2002. I was informed that the audit went very well and that your site was well organized with good attention to protocol adherence and study conduct."-- A Clinical Research Specialist
DuPont Clinical Research, Inc
Principal Investigator: Caroline DuPont, M.D
DCR 01 Merck Melancholia 2001 DCR 02 GSK MDD 2001 DCR 03 Merck Geriatric MDD 2001 DCR 04 Wyeth Panic 2002 DCR 05 GSK Depression 2002 DCR 06 Merck GAD 2002 DCR 07 Wyeth MDD 2002 DCR 08 Merck Geriatric MDD 2002 DCR 09 GSK Seasonal Affective 2002 DCR 10 GSK Sex. Funct./MDD 2003 DCR 11 Wyeth MDD 2003 DCR 12 GSK Geriatric Depr. 2003 DCR 13 GSK Seasonal Affective 2003 DCR 14 Quintiles Depr. & Insomnia 2004 DCR 15 Wyeth MDD Extension 2004 DCR 16 Wyeth Depression 2004 DCR 17 I3/Lilly GAD 2004 DCR 18 Merck Geriatric Insomnia 2004 DCR 19 Cephalon GAD 2004 DCR 20 Merck Adult Insomnia 2004 DCR 21 Wyeth Hot Flash 2004 DCR 22 Cephalon Ext. GAD 2005 DCR 23 BMS Bipolar 2005 DCR 24 BMS Tx Resistant MDD 2005 DCR 25 BMS Tx Resistant Extens 2006 DCR 26 Sepracor GAD/Insomnia 2005 DCR 27 Avera Social Anxiety 2006 DCR 28 Pfizer Bipolar Mania 2006 DCR 29 I3/Sanofi MDD 2006 DCR 30 I3/Sanofi GAD 2006 DCR 31 Wyeth Hot Flash 2006 DCR 32 BMS MDD 2006 DCR 33 Wyeth MDD 2006 DCR 34 Novartis Depression 2007 DCR 35 Pfizer Bipolar Depression 2007 DCR 36 Pfizer Generilzed Anxiety Disorder 2007 Call us at 301.231.9011.
"Dear Dr. DuPont and Florence:
I am writing to commend you and your site staff on your exemplary recruitment efforts for the [insomnia] trial."-- From a project manager 1/20/06
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