| Integrated monitoring: Setting new standards for the next decade of clinical trial practice. | |
| | |
MedLine Citation:
|
PMID: 21584179 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
|
The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor's organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic. |
| | |
Authors:
|
Kamala Rai |
Related Documents
:
|
21692719 - A therapeutic equivalence program: evidence-based promotion of more efficient use of me... 9644419 - Clinical management protocols: the bedside answer to clinical practice guidelines. 7153449 - Superficial punctate keratitis of thygeson. 22192159 - Obesity management and continuing medical education in primary care: results of a swiss... 19072339 - Circumferential and focal radiofrequency ablation for the treatment of barrett's esopha... 15679789 - The role of urinary urgency and its measurement in the overactive bladder symptom syndr... 15726049 - Advanced training in pediatric emergency medicine in the united states, canada, united ... 14508899 - Practicing beautiful medicine beautifully: hiram curry's vision in the 21st century. 19962679 - The effect of an educational intervention on patients' knowledge about hypertension, be... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Perspectives in clinical research Volume: 2 ISSN: 2229-5488 ISO Abbreviation: Perspect Clin Res Publication Date: 2011 Jan |
Date Detail:
|
Created Date: 2011-05-17 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101551517 Medline TA: Perspect Clin Res Country: India |
Other Details:
|
Languages: eng Pagination: 28-33 Citation Subset: - |
Affiliation:
|
Head- Clinical Development, International Clinical Research Operations, Novartis Healthcare Pvt. Ltd., Mumbai, Maharashtra, India. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Adaptive designs in clinical trials.
Next Document: Quality assurance: Importance of systems and standard operating procedures.