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Items: 1 to 20 of 100

1.

Monitoring and ensuring safety during clinical research.

Morse MA, Califf RM, Sugarman J.

JAMA. 2001 Mar 7;285(9):1201-5.

PMID:
11231751
2.

American Society of Clinical Oncology policy statement: oversight of clinical research.

American Society of Clinical Oncology..

J Clin Oncol. 2003 Jun 15;21(12):2377-86.

PMID:
12721281
3.

Toward protecting the safety of participants in clinical trials.

Califf RM, Morse MA, Wittes J, Goodman SN, Nelson DK, DeMets DL, Iafrate RP, Sugarman J.

Control Clin Trials. 2003 Jun;24(3):256-71.

PMID:
12757992
4.

Ensuring participant safety and trial integrity with clinical trials oversight.

Godfrey C, Payton M, Tasker S, Proestel S, Schouten JT.

J Acquir Immune Defic Syndr. 2014 Jan 1;65 Suppl 1:S40-3. doi: 10.1097/QAI.0000000000000041.

5.

The role of local institutional review boards in protecting human research subjects.

Burman WJ, Schooley RT.

JAMA. 2001 Jun 6;285(21):2713. No abstract available.

PMID:
11386919
6.

Breaking the camel's back: multicenter clinical trials and local institutional review boards.

Burman WJ, Reves RR, Cohn DL, Schooley RT.

Ann Intern Med. 2001 Jan 16;134(2):152-7.

PMID:
11177319
8.

Data monitoring boards in the pharmaceutical industry.

Herson J.

Stat Med. 1993 Mar;12(5-6):555-61; discussion 563.

PMID:
8493431
9.

Principles of good clinical practice (GCP) in clinical research.

Switula D.

Sci Eng Ethics. 2000 Jan;6(1):71-7.

PMID:
11273440
10.

Problems with Institutional Review Board inconsistency.

Veatch RM.

JAMA. 1982 Jul 9;248(2):179-80.

PMID:
7045427
11.

Ethical issues during the conduct of clinical trials.

Silverman H.

Proc Am Thorac Soc. 2007 May;4(2):180-4; discussion 184.

PMID:
17494728
12.

Clinical trials and treatment effects monitoring.

Meinert CL.

Control Clin Trials. 1998 Dec;19(6):515-22; discussion 523-43.

PMID:
9875833
13.

[Quality control in clinical trials].

Fukushima M.

Gan To Kagaku Ryoho. 1996 Jan;23(2):172-82. Review. Japanese.

PMID:
8611045
14.

Some FDA perspectives on data monitoring in clinical trials in drug development.

O'Neill RT.

Stat Med. 1993 Mar;12(5-6):601-8; discussion 609-14.

PMID:
8493434
15.

The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases.

Ellenberg SS, Myers MW, Blackwelder WC, Hoth DF.

Stat Med. 1993 Mar;12(5-6):461-7; discussion 469.

PMID:
8493424
16.

Paradigm shifts in clinical trials enabled by information technology.

Marks RG, Conlon M, Ruberg SJ.

Stat Med. 2001 Sep 15-30;20(17-18):2683-96.

PMID:
11523076
17.

A survey of monitoring practices in cancer clinical trials.

George SL.

Stat Med. 1993 Mar;12(5-6):435-50.

PMID:
8493422
18.

Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.

MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.

19.

Use of human subjects in experimentation. Institutional review boards: purposes, protocols, legal responsibilities.

Knepper JD.

J Am Med Rec Assoc. 1982 Oct;53(5):97-101. No abstract available.

PMID:
10298700
20.

Participants' perspectives on safety monitoring in clinical trials.

Flynn KE, Kramer JM, Dombeck CB, Weinfurt KP.

Clin Trials. 2013 Aug;10(4):552-9. doi: 10.1177/1740774513484394.

PMID:
23644503
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