Guidance for industry : computerized systems used in clinical investigations.

Guidance for industry : information program on clinical trials for serious or life-threatening diseases and conditions.
Published: (2002)

Guidance for industry : E 10 choice of control group and related issues in clinical trials.
Published: (2001)

Guidance for industry : toxicity grading schedule for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.
Published: (2007)

Guidance for industry : E9 statistical principles for clinical trials.
Published: (1998)

Guidance for industry : collection of race and ethnicity data in clinical trials.
Published: (2005)

Guidance for industry : gene therapy clinical trials, observing subjects for delayed adverse events.
Published: (2006)

Guidance for industry : submitting and reviewing complete responses to clinical holds.
Published: (2000)

Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors.
Published: (2006)

Guidance for industry : E2BM data elements for transmission of individual case safety reports.
Published: (2002)

Guidance for clinical trial sponsors : establishment and operation of clinical trial data monitoring committees.
Published: (2006)

Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers.
Published: (2005)

Guidance for industry : M4, the CTD, general questions and answers.
Published: (2004)

Guidance for industry : M4, the CTD, efficacy questions and answers.
Published: (2004)

The role of general clinical research centers in clinical trials : a characterization with recommendations /
by: Hopwood, Marsha
Published: (1980)

Guidance for industry : postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act.
Published: (2009)

Guidance for industry : independent consultants for biotechnology clinical trial protocols.
Published: (2004)

Guidance for industry : M4S, the CTD, safety.
Published: (2001)

Guidance for industry : M4S, the CTD, safety appendices.
Published: (2001)

Guidance for industry : M4E, the CTD, efficacy.
Published: (2001)

A first-order characterization of clinical trials /
by: Hopwood, Marsha
Published: (1980)

Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
Published: (2001)

The Clinical research process in the pharmaceutical industry /
Published: (1984)

Guidance for industry : granularity document : annex to M4, organization of the CTD.
Published: (2005)

Guidance for industry : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer.
Published: (2004)

Developing a national registry of pharmacologic and biologic clinical trials : workshop report /
Published: (2006)

caBIG clinical connector : clinical trials integration tool.
Published: (2010)

Small clinical trials : issues and challenges /
Published: (2001)

Guidance for industry : M4Q, the CTD, quality.
Published: (2001)

Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Published: (2008)

Reviewer guidance : conducting a clinical safety review of a new product application and preparing a report on the review.
Published: (2005)

PLoS clinical trials.
Published: (2006)

Clinical trials roadmap for physician practices /
by: Morgan, Christie L.
Published: (2004)

Cancer clinical trials at the National Institutes of Health Clinical Center : questions and answers.
Published: (2006)

eClinical trials : planning and implementation /
by: Kush, Rebecca Daniels
Published: (2003)

Management of data in clinical trials /
by: McFadden, Eleanor, 1948-
Published: (2007)

Guideline for the monitoring of clinical investigations.
Published: (1988)