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Celebrating our 20th Year of Regulatory Excellence!
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APRIL 1, 2022
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Book CG1: 2022 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials
$ 45.95
Book 1B: 2022 FDA Good Clinical Practice Guide
$ 19.95
Book 1A: 2022 Selected Regulations & Guidance for Drug Studies
$ 19.95
Book 2: 2022 Selected Regulations and Guidance for Medical Device Studies
$ 19.95
Book 3A: 2022 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
$ 18.95
Book 3B: 2022 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research
$ 17.95
Book 3C: 2022 The Official Investigator's Handbook for Conducting Cancer Clinical Trials
$ 18.95
Book 3D: 2022 Common Terminology Criteria for Adverse Events (CTCAE)
$ 13.95
Book 4: 2022 Selected Regulations/Guidance on Good Manufacturing Practice
$ 18.95
Book 4B: 2022 International Reference on Cleaning Validation under Good Manufacturing Practice
$ 18.95
Book 4C: 2022 Good Manufacturing Practice in the European Union, Reference Guide
$ 18.95
Book 5A: 2022 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance
$ 17.95
Book 5B: 2022 HIPAA Privacy for Researchers: Guidance from the NIH
$ 17.95
Book 6: 2022 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki
$ 19.95
Book 7: 2022 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling
$ 17.95
Book 8: 2022 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process
$ 17.95
Book 9: 2022 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research
$ 17.95
Book 10: 2022 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice
$ 18.95
Book 11: 2022 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada
$ 18.95
Book 13: 2022 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials
$ 17.95
Book 14: 2022 Selected Recently-Finalized FDA Guidance Documents
$ 18.95
Book 16: 2022 Preambles to Good Clinical Practice Regulations
$ 28.95
Book 17: 2022 Preambles to Good Manufacturing Practice Regulations
$ 24.95
Book 19: 2022 Preambles to Good Laboratory Practice Regulations
$ 22.95
Book 20: 2022 ORI Introduction to the Responsible Conduct of Research
$ 17.95
Book 22: 2022 Frequently Asked Questions and Guidance on Clinical Research from the OHRP
$ 17.95
Book 23: 2022 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures
$ 17.95
Book 24A: EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules
$ 28.95
Book 24B: EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes
$ 28.95
Book 25: 2022 Laws, Regulations, and Guidance on Pediatric Studies
$ 17.95
Book 27: 2022 FDA Investigations Operations Manual
$ 31.95
Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines
$ 19.95
Book 29: 2022 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans
$ 19.95
Book M1: 2022 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A)
$ 12.95
Book M2: 2022 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312 (Does not include Part 314 or any ICH Guidelines)
$ 12.95
Book M4: 2022 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary
$ 12.95
