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Celebrating 21 YEARS of Regulatory Excellence!
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Now Available: Revised APRIL 1, 2023 Books!      Also check out our NEW Book:  Good Clinical Practice Regulations in the US & the EU  (Book 1C)!

Select from All 2023 Books (Shipping in Mid-May)

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Book CG1: 2023 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials Book CG1: 2023 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 45.95
Book 1A: 2023 Selected Regulations & Guidance for Drug Studies Book 1A: 2023 Selected Regulations & Guidance for Drug Studies $ 20.95
Book 1B: 2023 FDA Good Clinical Practice Guide Book 1B: 2023 FDA Good Clinical Practice Guide $ 19.95
Book 1C: Good Clinical Practice Regulations in the US & the EU Book 1C: Good Clinical Practice Regulations in the US & the EU - $ 22.95
Book 2: 2023 Selected Regulations and Guidance for Medical Device Studies Book 2: 2023 Selected Regulations and Guidance for Medical Device Studies $ 19.95
Book 3A: 2023 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities Book 3A: 2023 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities $ 18.95
Book 3B: 2023 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research Book 3B: 2023 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 17.95
Book 3C: 2023 The Official Investigator's Handbook for Conducting Cancer Clinical Trials Book 3C: 2023 The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 18.95
Book 3D: 2023 Common Terminology Criteria for Adverse Events (CTCAE) Book 3D: 2023 Common Terminology Criteria for Adverse Events (CTCAE) $ 13.95
Book 4: 2023 Selected Regulations/Guidance on Good Manufacturing Practice Book 4: 2023 Selected Regulations/Guidance on Good Manufacturing Practice $ 18.95
Book 4B: 2023 International Reference on Cleaning Validation under Good Manufacturing Practice Book 4B: 2023 International Reference on Cleaning Validation under Good Manufacturing Practice $ 18.95
Book 4C: 2023 Good Manufacturing Practice in the European Union, Reference Guide Book 4C: 2023 Good Manufacturing Practice in the European Union, Reference Guide $ 18.95
Book 5A: 2023 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance Book 5A: 2023 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance $ 17.95
Book 5B: 2023 HIPAA Privacy for Researchers: Guidance from the NIH Book 5B: 2023 HIPAA Privacy for Researchers: Guidance from the NIH $ 17.95
Book 6: 2023 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki Book 6: 2023 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 19.95
Book 7: 2023 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling Book 7: 2023 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling $ 17.95
Book 8: 2023 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process Book 8: 2023 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process $ 17.95
Book 9: 2023 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research Book 9: 2023 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research $ 17.95
Book 11: 2023 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada Book 11: 2023 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada $ 18.95
Book 13: 2023 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials Book 13: 2023 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials $ 17.95
Book 14: 2023 Selected Recently-Finalized FDA Guidance Documents Book 14: 2023 Selected Recently-Finalized FDA Guidance Documents $ 18.95
Book 16: 2023 Preambles to Good Clinical Practice Regulations Book 16: 2023 Preambles to Good Clinical Practice Regulations $ 28.95
Book 17: 2023 Preambles to Good Manufacturing Practice Regulations Book 17: 2023 Preambles to Good Manufacturing Practice Regulations $ 24.95
Book 19: 2023 Preambles to Good Laboratory Practice Regulations Book 19: 2023 Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20: 2023 ORI Introduction to the Responsible Conduct of Research Book 20: 2023 ORI Introduction to the Responsible Conduct of Research $ 17.95
Book 22: 2023 Frequently Asked Questions and Guidance on Clinical Research from the OHRP Book 22: 2023 Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 17.95
Book 23: 2023 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures Book 23: 2023 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 17.95
Book 24A: EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules Book 24A: EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 28.95
Book 24B: EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes Book 24B: EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 28.95
Book 25: 2023 Laws, Regulations, and Guidance on Pediatric Studies Book 25: 2023 Laws, Regulations, and Guidance on Pediatric Studies $ 17.95
Book 27: 2023 FDA Investigations Operations Manual Book 27: 2023 FDA Investigations Operations Manual $ 31.95
Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines 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 Book 29: 2022 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans $ 19.95
Book M1: 2023 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M1: 2023 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 12.95
Book M2: 2023 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) Book M2: 2023 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: 2023 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary Book M4: 2023 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 12.95