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CG1:  2021 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials CG1: 2021 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 44.95
Book 1A:  2021 Selected Regulations & Guidance for Drug Studies Book 1A: 2021 Selected Regulations & Guidance for Drug Studies $ 17.95
Book 1B:  2021 FDA Good Clinical Practice Guide Book 1B: 2021 FDA Good Clinical Practice Guide $ 17.95
Book 2:  2021 Selected Regulations and Guidance for Medical Device Studies Book 2: 2021 Selected Regulations and Guidance for Medical Device Studies $ 17.95
Book 3A:  2021 Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities Book 3A: 2021 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities $ 15.95
Book 3B:  2021 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research Book 3B: 2021 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 15.95
Book 3C:  2021 The Official Investigator's Handbook for Conducting Cancer Clinical Trials Book 3C: 2021 The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 15.95
Book 3D:  2021 Common Terminology Criteria for Adverse Events (CTCAE) Book 3D: 2021 Common Terminology Criteria for Adverse Events (CTCAE) $ 11.95
Book 4:  2021 Selected Regulations/Guidance on Good Manufacturing Practice Book 4: 2021 Selected Regulations/Guidance on Good Manufacturing Practice $ 16.95
Book 4B:  2021 International Reference on Cleaning Validation under Good Manufacturing Practice Book 4B: 2021 International Reference on Cleaning Validation under Good Manufacturing Practice $ 16.95
Book 4C:  2021 Good Manufacturing Practice in the European Union, Reference Guide Book 4C: 2021 Good Manufacturing Practice in the European Union, Reference Guide $ 15.95
Book 5A:  2021 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance Book 5A: 2021 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance $ 15.95
Book 5B:  2021 HIPAA Privacy for Researchers: Guidance from the NIH Book 5B: 2021 HIPAA Privacy for Researchers: Guidance from the NIH $ 15.95
Book 6:  2021 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki Book 6: 2021 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 15.95
Book 7:  2021 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling Book 7: 2021 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling $ 15.95
Book 8:  2021 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process Book 8: 2021 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process $ 15.95
Book 9:  2021 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research Book 9: 2021 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research $ 15.95
Book 10:  2021 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice Book 10: 2021 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice $ 16.95
Book 11: 2021 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada Book 11: 2021 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada $ 16.95
Book 13:  2021 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials Book 13: 2021 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials $ 15.95
Book 14:  2021 Selected Recently-Finalized FDA Guidance Documents Book 14: 2021 Selected Recently-Finalized FDA Guidance Documents $ 16.95
Book 16:  2021 Preambles to Good Clinical Practice Regulations Book 16: 2021 Preambles to Good Clinical Practice Regulations $ 26.95
Book 17:  2021 Preambles to Good Manufacturing Practice Regulations Book 17: 2021 Preambles to Good Manufacturing Practice Regulations $ 22.95
Book 19:  2021 Preambles to Good Laboratory Practice Regulations Book 19: 2021 Preambles to Good Laboratory Practice Regulations $ 22.95
Book 20:  2021 ORI Introduction to the Responsible Conduct of Research Book 20: 2021 ORI Introduction to the Responsible Conduct of Research $ 15.95
Book 21:  2021 Pharmaceutical Administration, Regulations, and Drug Development in Japan Book 21: 2021 Pharmaceutical Administration, Regulations, and Drug Development in Japan $ 15.95
Book 22:  2021 Frequently Asked Questions and Guidance on Clinical Research from the OHRP Book 22: 2021 Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 15.95
Book 23:  2021 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures Book 23: 2021 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 15.95
Book 24A:  EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules Book 24A: EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 26.95
Book 24B:  EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes Book 24B: EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 26.95
Book 25:  2021 Laws, Regulations, and Guidance on Pediatric Studies Book 25: 2021 Laws, Regulations, and Guidance on Pediatric Studies $ 15.95
Book 27:  2021 FDA Investigations Operations Manual Book 27: 2021 FDA Investigations Operations Manual $ 29.95
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 $ 17.95
Book 29:  2021 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans Book 29: 2021 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans $ 17.95
Book M4:  2021 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary Book M4: 2021 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 10.95
Book M1:  2021 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) Book M1: 2021 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 10.95
Book M2:  2021 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: 2021 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) $ 10.95