1. Maintaining the Highest Ethical Standard in Publishing

   • Stephen P. Spielberg

   Editorial 30 December 2016 Pages: 396 - 396

2. TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework

   • Ann Meeker-O’Connell
   • Leslie M. Sam
   • Janis A. Little

   Sponsored Special Section by TransCelerate BioPharma: Analytical Report Open access 30 December 2016 Pages: 397 - 413

3. Regulatory System Changes in Russia: A Historical Review and Future Perspectives

   • Raimond Lozda

   Global Perspectives: Review 30 December 2016 Pages: 414 - 418

4. Use of Medical Mobile Applications Among Hospital Pharmacists in Malaysia

   • Long Chiau Ming
   • Mohammed Abdul Hameed
   • Tahir Mehmood Khan

   Global Perspectives: Original Research 30 December 2016 Pages: 419 - 426

5. Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label

   • Vivien Tong
   • David K. Raynor
   • Parisa Aslani

   Global Perspectives: Original Research 30 December 2016 Pages: 427 - 435

6. The Impact of Protocol Amendments on Clinical Trial Performance and Cost

   • Kenneth A. Getz
   • Stella Stergiopoulos
   • Derek Dunn

   Clinical Trials: Original Research 30 December 2016 Pages: 436 - 441

7. Mobile Nurse Services in Clinical Trials: Usage and Industry Perceptions

   • Stella Stergiopoulos
   • Conor Eustace
   • Kenneth A. Getz

   Clinical Trials: Original Research 30 December 2016 Pages: 442 - 449

8. An Overview of the Regulatory and Developmental Strategies of Chronotherapeutics

   • Mohd. Aamir Mirza
   • Faiyaz Shakeel
   • Zeenat Iqbal

   Clinical Trials: Review 30 December 2016 Pages: 450 - 454

9. Reporting Adverse Drug Reactions in Product Labels

   • Brenda Crowe
   • Christy Chuang-Stein
   • Andreas Brueckner

   Product Safety: Analytical Report 30 December 2016 Pages: 455 - 463

10. Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance

    • Rishi Kumar
    • Pranay Kumar
    • G. N. Singh

    Product Safety: Original Research 30 December 2016 Pages: 464 - 471

11. Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First Approval

    • Nobuyuki Sekine
    • Yasuo Ohashi
    • Atsushi Aruga

    Product Safety: Original Research 30 December 2016 Pages: 472 - 479

12. Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

    • Jaime Arango
    • Tina Chuck
    • Gretchen Wild

    Regulatory Science: Review Open access 30 December 2016 Pages: 480 - 486

13. Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

    • Magdalena Bujar
    • Neil McAuslane
    • Stuart Walker

    Regulatory Science: Original Research 30 December 2016 Pages: 487 - 495

14. Using Contour Plots to Assess the Sensitivity of Clinical Trial Design Assumptions

    • Richard C. Zink
    • Xiaotong Jiang

    Statistics: Original Research 30 December 2016 Pages: 496 - 509

15. Process Innovation Improves Trial Operation Efficiency

    • Yun Jung Choi
    • Kyu-pyo Kim
    • Tae Won Kim

    Product Development and Innovation: Original Research 30 December 2016 Pages: 510 - 514

16. Institutional Review Boards as Arbiters of Expanded Access to Unapproved Drugs: Time for a Change?

    • Barbara K. Redman
    • Alison Shea Bateman-House

    Policy: Commentary 30 December 2016 Pages: 515 - 516

17. Erratum to: Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials

    • A. Gnanasakthy
    • C. DeMuro

    Erratum 30 December 2016 Pages: 517 - 517