A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd

Investigators

The following articles on this topic have been published in CRAdvisor (CRA) – the year, issue number and starting page number for each are listed below:

Back to index

2007  
CRA 2007; 192:1 FDA guidance on the supervisory responsibilities of investigators.
CRA 2007; 192:7 CDER issues new warnings to investigators.
CRA 2007; 194:3 New FDA guidance reminds investigators of supervisory responsibilities.
CRA 2007; 194:7 Observant monitor spots signs of fraud leading to investigator prosecution.
   
2006  
CRA 2006; 167:6 Documents, archiving and inspections - how much can the sponsor help the trial investigator?
CRA 2006; 173:7 European investigator survey.
CRA 2006; 175:2 Overpayments to investigators exposed in Sweden.
CRA 2006; 178:1 Investigator jailed for 57 months.
   
2005  
CRA 2005; 143:3 Principal investigator accountable for site deficiencies.
CRA 2005; 146:5 OHRP guidance on collaborating investigators.
CRA 2005; 152:3 How harmonised is SAE reporting to investigators?
CRA 2005; 156:6 Proactive principal investigators aid patient recruitment.
CRA 2005; 160:4 Identifying the most frequent violations of FDA regulations.
CRA 2005; 161:1 Are our investigators selling drug secrets?
CRA 2005; 161:7 US investigators under pressure.
   
2004  
CRA 2004; 123:1 Investigator challenges EMEA in attempt to overturn new product marketing approval.
CRA 2004; 126:4 Book review: Guide for clinical trial staff by Gerhard Fortwengel.
CRA 2004; 130:2 Further guidance for academic research in the UK.
CRA 2004; 140:5 Concerns persist about investigator-initiated trials.
   
2003  
CRA 2003; 106:3 Quality improvement advice for investigator sites.
CRA 2003; 110:6 New publications from BARQA.
CRA 2003; 114:7 DIA to commence investigator training initiative.
   
2002  
CRA 2002; 81:6 Ban for investigator.
CRA 2002; 87:5 Consent, discontent and disclosure.
   
2001  
CRA 2001; 72:4 Can templates be used by investigators to record trial data.
CRA 2001; 77:4 Should code breakers be on site?
CRA 2001; 80:7 FDA and sponsor-investigator research.
   
2000  
CRA 2000; 42:1 Did Dr. Shipman do your trials? 
CRA 2000; 42:1 Investigator incurs wrath of FDA. 
CRA 2000; 43:3 Investigator must supervise the trial! 
CRA 2000; 47:6 Doctor censored. 
CRA 2000; 48:1 Poor GCP compliance by investigator is still major source of concern. 
CRA 2000: 50:1 Investigator used study drug when IND was on hold. 
CRA 2000; 51:6 New patient protection strategies in USA. 
CRA 2000; 55:4 Investigator GCP training must be taken seriously. 
CRA 2000: 56:5 Encouraging investigators to join the e-revolution. 
CRA 2000; 59:1 Investigator need may jeopardise trial subject safety.
   
1999  
CRA 1999; 20:6 Will Ethics Committees cap the recruitment time? 
CRA 1999; 22:2 Investigator Internet network improves recruitment. 
CRA 1999; 23:3 Concern raised about investigator understanding of responsibilities. 
CRA 1999; 23:5 Are suspended Doctors doing your trials? 
CRA 1999; 24:1 Can only doctors be investigators? 
CRA 1999; 24:2 Action against non-compliant sponsors and investigators. 
CRA 1999; 25:2 Practical advice on recruiting elderly patients. 
CRA 1999; 25:2 Electronic communications and clinical trials. 
CRA 1999; 29:1 Most patient enrolment deadlines are missed. 
CRA 1999; 30:6 Doctor only investigators rejected. 
CRA 1999; 31:1 Time for a European investigator blacklist. 
CRA 1999; 33:6 Test for investigators. 
CRA 1999; 35:6 Media ads for patient recruitment. 
CRA 1999; 36:3 Keys to successful subject recruitment. 
CRA 1999; 37:5 Going on the attack – a new way to recruit stroke patients to clinical trials. 
   
1998  
CRA 1998; 3:4 Are trial nurses more important than monitors? 
CRA 1998; 4:4 Good monitoring practice. 
CRA 1998; 12:1 Poor levels of GCP compliance by investigators. 
CRA 1998; 12:4 Certification for investigators moves ahead. 
CRA 1998; 16:2 Beware of the hazards of fast-track recruitment. 
CRA 1998; 16:4 A time limit for data queries? 
CRA 1998; 16:5 Tips on patient recruitment and study management. 

Top