Site organization and management

Inflammatory Bowel Diseases

Volumn 11, Issue SUPPL. 1, 2005, Pages

  Wolf, Douglas C ^a   Katz, Seymour ^b   Safdi, Michael A ^c   Sandler, Robert S ^d   Lewis, James D ^e   Merrick, Marjorie ^f  

^a Atlanta Gastroenterology Associates   (United States)

^b Long Island Clinical Research Associates   (United States)

^c Greater Cincinnati Gastroenterology Associates   (United States)

^d UNIVERSITY OF NORTH CAROLINA   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f Crohn's and Colitis Foundation of America   (United States)

Author keywords

Clinical research; FDA form 1572; Informed consent; Patient recruitment; Site management; Standard operating procedure

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; ENTERITIS; GOOD CLINICAL PRACTICE; INFORMED CONSENT; MEDICAL SPECIALIST; ORGANIZATION; PATIENT CARE; PATIENT SELECTION; PERSONNEL; PRIORITY JOURNAL; SPACE; STANDARDIZATION; TIME;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; FORMS AND RECORDS CONTROL; GASTROENTEROLOGY; HUMANS; PATIENT SELECTION; QUALITY ASSURANCE, HEALTH CARE;

EID: 27644493293     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/01.MIB.0000184848.61687.52     Document Type: Article

References (13)

1. The Code of Federal Regulations. GCP/ICH Guidelines. Washington, DC: GMP Publications; 2004.
2. Miskin BM, Neuer A. How to Grow Your Investigative Site: A Guide to Operating and Expanding a Successful Clinical Research Center. Center-Watch. Stamford, CT: Thomson Healthcare; 2002.
3. Colon L, Richardson B, Palmer L, et al. Development of Effective Standard Operating Procedures (SOPs) for Clinical Research Sites. Anaheim, CA: ACRP; 1998.
4. Anderson DL. Community, physician and consumer outreach strategies to meet recruitment goals. In: A Guide to Patient Recruitment and Retention. Dallas, TX: D Anderson & Co; 2004:179-197.
5. Gamache V. Minimizing Volunteer Dropout. CenterWatch. Stamford, CT: Thomson Healthcare; 2002:19(Issue 12).
6. Getz KA. Study Volunteer Behaviors and Attitudes in Industry-Sponsored Clinical Trials. Presented at the Institute of Medicine's Clinical Research Roundtable, Washington, DC, September 25, 2000.
7. Getz KA. Benchmarking patient recruitment and retention in clinical trials. In: A Guide to Patient Recruitment and Retention. Dallas, TX: D Anderson & Co; 2004:25-44.
8. Good PI. A Manager's Guide to the Design and Conduct of Clinical Trials. New York, NY: Wiley-Liss; 2002.
9. Needham J. The importance of retention. In: A Guide to Patient Recruitment and Retention. Dallas, TX: D Anderson & Co; 2004;167-177.
10. Neuer A. Treating Study Volunteers as Customers. CenterWatch. Stamford, CT: Thomson Healthcare; 2003.
11. Norris D. Clinical Research Coordinator Handbook. 3rd ed. Medford, NJ: Plexus Publishing; 2004.
12. The Center for Clinical Research Practice. GCP education, training, and SOP templates, http://www.ccrp.com
13. Woolley M. Research! American Poll Data on Attitudes toward Medical Research. Presented at the Institute of Medicine's Clinical Research Roundtable, Washington, DC, September 15, 2000.