1

Your cart is empty.

The Most-Trusted Regulations & Guidelines Books on the Market.
Celebrating 19 Years of Excellence.


Now shipping orders for our April 1, 2020 Books

Also accepting PRE-ORDERS for our REVISED APRIL 1, 2021 BOOKS shipping in May.

PRE-ORDER 2021: Select from All Books

Enter the quantities of all of the books that you want, then click the "Add to the cart" button.  If you click on a book's title to review its content, use the BACK ARROW on your browser or the "Return to Previous Page" link to return to this form so that you do not erase your order quantities.  You can always adjust your quantities in your shopping cart.

PRE-ORDER CG1:  2021 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials PRE-ORDER CG1: 2021 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials $ 44.95
PRE-ORDER Book 1A:  2021 Selected Regulations & Guidance for Drug Studies PRE-ORDER Book 1A: 2021 Selected Regulations & Guidance for Drug Studies $ 16.95
PRE-ORDER Book 1B:  2021 FDA Good Clinical Practice Guide PRE-ORDER Book 1B: 2021 FDA Good Clinical Practice Guide $ 16.95
PRE-ORDER Book 2:  2021 Selected Regulations and Guidance for Medical Device Studies PRE-ORDER Book 2: 2021 Selected Regulations and Guidance for Medical Device Studies $ 16.95
PRE-ORDER Book 3A:  2021 Selected Regulations and Guidance on Protection of Human Subjects:  Clinical Investigator, IRB & Sponsor Responsibilities PRE-ORDER Book 3A: 2021 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities $ 15.95
PRE-ORDER Book 3B:  2021 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research PRE-ORDER Book 3B: 2021 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research $ 15.95
PRE-ORDER Book 3C:  2021 The Official Investigator's Handbook for Conducting Cancer Clinical Trials PRE-ORDER Book 3C: 2021 The Official Investigator's Handbook for Conducting Cancer Clinical Trials $ 15.95
PRE-ORDER Book 3D:  2021 Common Terminology Criteria for Adverse Events (CTCAE) PRE-ORDER Book 3D: 2021 Common Terminology Criteria for Adverse Events (CTCAE) $ 11.95
PRE-ORDER Book 4:  2021 Selected Regulations/Guidance on Good Manufacturing Practice PRE-ORDER Book 4: 2021 Selected Regulations/Guidance on Good Manufacturing Practice $ 16.95
PRE-ORDER Book 4B:  2021 International Reference on Cleaning Validation under Good Manufacturing Practice PRE-ORDER Book 4B: 2021 International Reference on Cleaning Validation under Good Manufacturing Practice $ 16.95
PRE-ORDER Book 4C:  2021 Good Manufacturing Practice in the European Union, Reference Guide PRE-ORDER Book 4C: 2021 Good Manufacturing Practice in the European Union, Reference Guide $ 15.95
PRE-ORDER Book 5A:  2021 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance PRE-ORDER Book 5A: 2021 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance $ 15.95
PRE-ORDER Book 5B:  2021 HIPAA Privacy for Researchers: Guidance from the NIH PRE-ORDER Book 5B: 2021 HIPAA Privacy for Researchers: Guidance from the NIH $ 15.95
PRE-ORDER Book 6:  2021 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki PRE-ORDER Book 6: 2021 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki $ 15.95
PRE-ORDER Book 7:  2021 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling PRE-ORDER Book 7: 2021 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling $ 15.95
PRE-ORDER Book 8:  2021 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process PRE-ORDER Book 8: 2021 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process $ 15.95
PRE-ORDER Book 9:  2021 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research PRE-ORDER Book 9: 2021 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research $ 15.95
PRE-ORDER Book 10:  2021 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice PRE-ORDER Book 10: 2021 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice $ 15.95
PRE-ORDER Book 11: 2021 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada PRE-ORDER Book 11: 2021 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada $ 15.95
Book 12: 2020 Selected Regulations/Guidance on GCP in India Book 12: 2020 Selected Regulations/Guidance on GCP in India $ 15.95
PRE-ORDER Book 13:  2021 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials PRE-ORDER Book 13: 2021 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials $ 15.95
PRE-ORDER Book 14:  2021 Selected Recently-Finalized FDA Guidance Documents PRE-ORDER Book 14: 2021 Selected Recently-Finalized FDA Guidance Documents $ 15.95
PRE-ORDER Book 16:  2021 Preambles to Good Clinical Practice Regulations PRE-ORDER Book 16: 2021 Preambles to Good Clinical Practice Regulations $ 26.95
PRE-ORDER Book 17:  2021 Preambles to Good Manufacturing Practice Regulations PRE-ORDER Book 17: 2021 Preambles to Good Manufacturing Practice Regulations $ 22.95
Book 18:  SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval Book 18: SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval $ 15.95
PRE-ORDER Book 19:  2021 Preambles to Good Laboratory Practice Regulations PRE-ORDER Book 19: 2021 Preambles to Good Laboratory Practice Regulations $ 22.95
PRE-ORDER Book 20:  2021 ORI Introduction to the Responsible Conduct of Research PRE-ORDER Book 20: 2021 ORI Introduction to the Responsible Conduct of Research $ 15.95
PRE-ORDER Book 21:  2021 Pharmaceutical Administration, Regulations, and Drug Development in Japan PRE-ORDER Book 21: 2021 Pharmaceutical Administration, Regulations, and Drug Development in Japan $ 15.95
PRE-ORDER Book 22:  2021 Frequently Asked Questions and Guidance on Clinical Research from the OHRP PRE-ORDER Book 22: 2021 Frequently Asked Questions and Guidance on Clinical Research from the OHRP $ 15.95
PRE-ORDER Book 23:  2021 Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures PRE-ORDER Book 23: 2021 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures $ 15.95
PRE-ORDER Book 24A:  EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules PRE-ORDER Book 24A: EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules $ 26.95
PRE-ORDER Book 24B:  EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes PRE-ORDER Book 24B: EU 2021 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes $ 26.95
PRE-ORDER Book 25:  2021 Laws, Regulations, and Guidance on Pediatric Studies PRE-ORDER Book 25: 2021 Laws, Regulations, and Guidance on Pediatric Studies $ 15.95
PRE-ORDER Book 27:  2021 FDA Investigations Operations Manual PRE-ORDER Book 27: 2021 FDA Investigations Operations Manual $ 29.95
PRE-ORDER Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA):  Survey Procedures and Interpretive Guidelines PRE-ORDER Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines $ 17.95
PRE-ORDER Book 29:  2021 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans PRE-ORDER Book 29: 2021 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans $ 17.95
PRE-ORDER Book M4:  2021 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary PRE-ORDER Book M4: 2021 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary $ 10.95
PRE-ORDER Book M1:  2021 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) PRE-ORDER Book M1: 2021 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A) $ 10.95
PRE-ORDER 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) PRE-ORDER 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