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Book CG1: 2022 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials Book CG1: 2022 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 45.95
Book 1B: 2022 FDA Good Clinical Practice Guide Book 1B: 2022 FDA Good Clinical Practice Guide $ 19.95
Book 1A: 2022 Selected Regulations & Guidance for Drug Studies Book 1A: 2022 Selected Regulations & Guidance for Drug Studies $ 19.95
Book 2: 2022 Selected Regulations and Guidance for Medical Device Studies 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 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 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 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) Book 3D: 2022 Common Terminology Criteria for Adverse Events (CTCAE) $ 13.95
Book 4: 2022 Selected Regulations/Guidance on Good Manufacturing Practice Book 4: 2022 Selected Regulations/Guidance on Good Manufacturing Practice $ 18.95
Book 4B: 2022 International Reference on Cleaning Validation under Good Manufacturing Practice 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 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 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 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 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 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 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 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 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 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 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 Book 14: 2022 Selected Recently-Finalized FDA Guidance Documents $ 18.95
Book 16: 2022 Preambles to Good Clinical Practice Regulations Book 16: 2022 Preambles to Good Clinical Practice Regulations $ 28.95
Book 17: 2022 Preambles to Good Manufacturing Practice Regulations Book 17: 2022 Preambles to Good Manufacturing Practice Regulations $ 24.95
Book 19: 2022 Preambles to Good Laboratory Practice Regulations Book 19: 2022 Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20: 2022 ORI Introduction to the Responsible Conduct of Research 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 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 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 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 Book 24B: EU 2022 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 28.95
Book 25: 2022 Laws, Regulations, and Guidance on Pediatric Studies Book 25: 2022 Laws, Regulations, and Guidance on Pediatric Studies $ 17.95
Book 27: 2022 FDA Investigations Operations Manual Book 27: 2022 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: 2022 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) 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) 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 Book M4: 2022 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 12.95
e-Books: Multiple 1-year Licenses Only $ 17.95