Journal of Clinical Research Best Practices Archives
454 insightful, practical and amusing articles that are still relevant
| Title | Authors | Date | View | Copy Link |
|---|---|---|---|---|
| Caught in the Middle: How Sponsors, Sites and CROs Can Work Together Effectively | Norman M. Goldfarb | MAY 2005 |
|
|
| The Study from Hell | Norman M. Goldfarb | MAY 2005 |
|
|
| The Nature of Sales: It’s More Than Just Getting An Order | Jeff Krawitz | JUN 2005 |
|
|
| How Safe Is Safe? Insurance for Investigative Sites | Norman M. Goldfarb and Michael Smith, Jr. | JUN 2005 |
|
|
| Hiring, Training, Managing and Retaining Study Coordinators | Norman M. Goldfarb | JUN 2005 |
|
|
| The Triumph of Hope Over Experience: Why Johnny Can’t Forecast Subject Enrollment | Norman M. Goldfarb | JUL 2005 |
|
|
| Study Eligibility and the Principle of Justice | Norman M. Goldfarb | JUL 2005 |
|
|
| What is Killing Off the Investigators? A Clinical Research Mystery | Norman M. Goldfarb | JUL 2005 |
|
|
| How Well Does the Average U.S. Adult Read? | Norman M. Goldfarb | SEP 2005 |
|
|
| Readable Informed Consent Forms Are Not Optional | Norman M. Goldfarb | SEP 2005 |
|
|
| Hurricane Katrina: There’s More Where that Came From | Norman M. Goldfarb | OCT 2005 |
|
|
| Subject Recruiting: The Missing Links | Norman M. Goldfarb | OCT 2005 |
|
|
| Avoiding Linguistic Landmines: Translating Informed Consent Forms Accurately | Inna Kassatkina | OCT 2005 |
|
|
| The True Cost of a Study Coordinator Hour | Norman M. Goldfarb | NOV 2005 |
|
|
| Bringing Method to the Madness: Protocol Deviation & Violation Codes | Norman M. Goldfarb | NOV 2005 |
|
|
| Ignorance of the Shipping Regulations May Be Hazardous to the Health of Your Business | Junius “Jay” Johnson and Norman M. Goldfarb | DEC 2005 |
|
|
| The Seven Hats of an IRB (and which Members Wear Them) | Norman M. Goldfarb | DEC 2005 |
|
|
| The Four Requirements for Profitable Clinical Research | Norman M. Goldfarb | DEC 2005 |
|
|
| Writing Good at a Seventh-Grade Reading Level | Norman M. Goldfarb and William H. DuBay | JAN 2006 |
|
|
| When Patents Became Interesting in Clinical Research | Norman M. Goldfarb | MAR 2006 |
|
|
| Ackerman on Kligman: A Shameful Story in American Clinical Research | Norman M. Goldfarb | APR 2006 |
|
|
| Assignment of Subjects to Clinical Studies | Norman M. Goldfarb | APR 2006 |
|
|
| Informed Consent Form Makeover | Norman M. Goldfarb and William DuBay | MAY 2006 |
|
|
| Treatment Reimbursement in Informed Consent Forms and Clinical Trial Agreements | Norman M. Goldfarb | MAY 2006 |
|
|
| Informed Consent in the TeGenero TGN1412 Trial | Norman M. Goldfarb | MAY 2006 |
|
|
| A Conceptual Model for Therapeutic Misconception and Equipoise | Norman M. Goldfarb | JUN 2006 |
|
|
| Who You Calling a Study Coordinator? | Norman M. Goldfarb | JUL 2006 |
|
|
| A Conceptual Model for Therapeutic Misconception and Equipoise | Norman M. Goldfarb | AUG 2006 |
|
|
| Name that Drug! The Side-Effect Game | Norman M. Goldfarb | AUG 2006 |
|
|
| The Two Dimensions of Subject Vulnerability | Norman M. Goldfarb | AUG 2006 |
|
|
| What Does the Investigator’s Signature Mean? | Charles Fogarty, Bernard Corbett, and Norman M. Goldfarb | SEP 2006 |
|
|
| Where Does the Time Go? | Norman M. Goldfarb | SEP 2006 |
|
|
| The Case of the Faulty Facility: Investigative Reporting on SFBC | Norman M. Goldfarb | OCT 2006 |
|
|
| Accelerating the Process of Negotiating Clinical Trial Agreements | Norman M. Goldfarb | OCT 2006 |
|
|
| Are Site Monitoring and Data Cleaning a Waste of Time? | Norman M. Goldfarb | NOV 2006 |
|
|
| Requirements for Study Coordinators | Norman M. Goldfarb | NOV 2006 |
|
|
| Making Informed Consent Work for All | Susan Brink | DEC 2006 |
|
|
| Managing Queues in the Clinical Trial Agreement Negotiation Process | Norman M. Goldfarb | DEC 2006 |
|
|
| Too Much Disaster Going On | Andrea Favalora and Norman M. Goldfarb | JAN 2007 |
|
|
| Unreported Clinical Research Fraud and Misconduct | JoAnn Jessen, Elizabeth Robinson, Suellen Bigaj, Sherry Popiolek, and Norman M. Goldfarb | JAN 2007 |
|
|
| Adverse Events before Drug Administration | Annette Kinsella | FEB 2007 |
|
|
| Research Records and the Resolution of Misconduct Allegations at Research Universities | Kenneth Wilson, Alan Schreier, Angel Griffin, and David Resnik | FEB 2007 |
|
|
| How to Solve the Quality Problem in Clinical Research | Norman M. Goldfarb | FEB 2007 |
|
|
| The Site Monitor Reborn as Consultant, Trainer and Manager | Michael Rosenberg and Norman M. Goldfarb | MAR 2007 |
|
|
| Adaptive Site Performance Management | Norman M. Goldfarb | APR 2007 |
|
|
| Legal Implications of Clinical Trial Sponsor Financial Support for Subject Heathcare Costs in Clinical Trials | John S. McInnes and Grant P. Bagley | APR 2007 |
|
|
| Cost Inflation in Clinical Research | Norman M. Goldfarb | APR 2007 |
|
|
| How Effective are Site Questionnaires in Predicting Site Performance? | Sherry Reuter and Gretchen Esche | APR 2007 |
|
|
| Ethical Pitfalls for Sponsors in Developing Countries | Norman M. Goldfarb | MAY 2007 |
|
|
| Reinventing the Site Questionnaire | Norman M. Goldfarb | MAY 2007 |
|
|
| A Risk-Based Approach for Assessing Data Quality | Kit Howard | JUN 2007 |
|
|
| Systematic Customer Service for Clinical Research Sites | Norman M. Goldfarb | JUN 2007 |
|
|
| SUMP Studies | Norman M. Goldfarb | JUN 2007 |
|
|
| Documenting Concomitant Medications in Clinical Trials | S. Eric Ceh | JUL 2007 |
|
|
| A Right to Benefit from International Research: A New Approach to Capacity Building in Less-Developed Countries | Mary Terrell White | JUL 2007 |
|
|
| Red Flags in the Study Office: Ann Marie Cisneros on the Ketek TREAT Study | Norman M. Goldfarb | AUG 2007 |
|
|
| How to Manage Any Organization | Norman M. Goldfarb | AUG 2007 |
|
|
| What Screening Is Permitted Prior to Informed Consent? | Michael R. Hamrell | AUG 2007 |
|
|
| Medical Malpractice Liability in Human Research | Fay A. Rozovsky and Rodney K. Adams | SEP 2007 |
|
|
| Informed Consent Witness Programs | Norman M. Goldfarb | SEP 2007 |
|
|
| Fun with Clinical Trial Budgeting and Accruals | Chris Chan | OCT 2007 |
|
|
| Therapeutic Misconception, or Not? | Norman M. Goldfarb | OCT 2007 |
|
|
| Subject Recruitment and Retention Biases | Norman M. Goldfarb | NOV 2007 |
|
|
| Clinical Research Site Overhead Costs | Norman M. Goldfarb | DEC 2007 |
|
|
| Data & Safety Monitoring Boards in Industry-Sponsored Clinical Trials | Cristian Sirbu, B. Daniel Lucas Jr., Mike Broce, and Norman M. Goldfarb | JAN 2008 |
|
|
| Season’s Greetings from Your IRB | David R. Karp | JAN 2008 |
|
|
| 18 Subject Injury and Indemnification CTA Loopholes | Norman M. Goldfarb and Aylin Regulski | JAN 2008 |
|
|
| Should You Be a Clinical Research Principal Investigator? | Norman M. Goldfarb | JAN 2008 |
|
|
| Don’t Ask, Don’t Tell? Transfer and Sale of De-Identified Patient Data | Gabrielle B. Goldstein and Jill H. Gordon | FEB 2008 |
|
|
| The Tranquil World of IND Safety Reports | Norman M. Goldfarb | FEB 2008 |
|
|
| Confucius on Clinical Research | Norman M. Goldfarb | MAR 2008 |
|
|
| To Pay or Not to Pay: How Do We Determine Participant Payment for a Clinical Study? | Elizabeth Ripley, Francis L. Macrina, Monika Markowitz, and Lloyd Byrd | MAR 2008 |
|
|
| Payments to Pediatric Subjects | Stephanie Lowenhaupt | MAR 2008 |
|
|
| What Is A Physician’s Time Worth? | Norman M. Goldfarb | MAR 2008 |
|
|
| Large CRO to Acquire FDA | Norman M. Goldfarb | APR 2008 |
|
|
| Don’t Ask, Don’t Tell? Transfer and Sale of De-Identified Patient Data | Gabrielle B. Goldstein and Jill H. Gordon | APR 2008 |
|
|
| Gimme Shelter: Anti-Kickback Safe Harbors and Clinical Trial Agreements | Debbie K. McAllister | MAY 2008 |
|
|
| Negotiation Research in the Markets of Beijing | Norman M. Goldfarb | MAY 2008 |
|
|
| Confidentiality Challenges in Clinical Trials | Norman M. Goldfarb | MAY 2008 |
|
|
| Case Report Form Insanity | Paul Latimer | MAY 2008 |
|
|
| Age of Consent for Clinical Research | Norman M. Goldfarb | JUN 2008 |
|
|
| Investigator-Initiated Research | Harvey M. Arbit | JUN 2008 |
|
|
| The Life of a Study Coordinator | Cheryl Ryan | JUN 2008 |
|
|
| Investigator Meeting Insanity | Paul Latimer | JUL 2008 |
|
|
| Screen Failures in Clinical Trials: Financial Roulette or the Cost of Doing Business? | Robert S. Bienkowski and Norman M. Goldfarb | JUL 2008 |
|
|
| The Personal Side of Subject Recruitment | Norman M. Goldfarb | AUG 2008 |
|
|
| Subject Illnesses Found at Screening | Joél Marie Barra | AUG 2008 |
|
|
| Site Monitors from Hell | Fran Dickson and Ruth Steele | AUG 2008 |
|
|
| Much Ado about Subject Compensation | Norman M. Goldfarb | SEP 2008 |
|
|
| Business Risks: Are You Protected? | Norman M. Goldfarb | SEP 2008 |
|
|
| Investigator Disclosures of Financial Conflicts | Norman M. Goldfarb | OCT 2008 |
|
|
| Non-Significant Risk Determinations: Just Because You Can Doesn’t Mean You Should | David Hammond | OCT 2008 |
|
|
| Individual vs. Community Rights in Clinical Research | Norman M. Goldfarb and Adil E. Shamoo | OCT 2008 |
|
|
| Study Coordinators from Hell | Tammy L. Morton-Taylor | OCT 2008 |
|
|
| The Art of Assessment: Performance Evaluation Co-monitoring Visits | Elizabeth Weeks | NOV 2008 |
|
|
| Sponsor Agreements with Research Sites and CROs | Norman M. Goldfarb | NOV 2008 |
|
|
| Stage Presence | Norman M. Goldfarb | NOV 2008 |
|
|
| Verifying and Validating Clinical Data Management Software | Sarah Hammond and David Hammond | NOV 2008 |
|
|
| The Informed Consent Decision Process | Norman M. Goldfarb | DEC 2008 |
|
|
| Social Benefits of Human Subjects Research | David B. Resnik | DEC 2008 |
|
|
| Documenting Clinically Significant Lab Values | S. Eric Ceh | JAN 2009 |
|
|
| Name that Drug! The Side-Effect Game | Norman M. Goldfarb | JAN 2009 |
|
|
| Proof of Consent | Norman M. Goldfarb | FEB 2009 |
|
|
| The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research | Jason Borenstein | FEB 2009 |
|
|
| 12 Publication Rights Loopholes in Clinical Trial Agreements | Aylin Regulski | FEB 2009 |
|
|
| Poor Richard on Clinical Research | Norman M. Goldfarb | FEB 2009 |
|
|
| Adverse Event Reporting: Site Preparation | S. Eric Ceh | MAR 2009 |
|
|
| Are Your Employees Destroying Your Business? | Mitchell Goozé | MAR 2009 |
|
|
| A challenging position is open for a qualified study coordinator. Do not miss this opportunity! | Norman M. Goldfarb | APR 2009 |
|
|
| Protocol Evaluation Questions | Norman M. Goldfarb | APR 2009 |
|
|
| Adventures in Air Travel | Norman M. Goldfarb | MAY 2009 |
|
|
| Handling Subject Complaints | Norman M. Goldfarb | MAY 2009 |
|
|
| The University of Rochester Research Subject Advocacy Program | Nancy A. Needler and Norman M. Goldfarb | MAY 2009 |
|
|
| Maintaining a Safe Workplace | Norman M. Goldfarb | JUN 2009 |
|
|
| Incidental Findings: A Common Law Approach | Stacey A. Tovino, J.D., Ph.D. | JUL 2009 |
|
|
| Investigator Signatures on Informed Consent Forms | Norman M. Goldfarb | JUL 2009 |
|
|
| Universal Precautions | Ubaid Hameed Shah and Mohammad Nasir Yousuf Shah | JUL 2009 |
|
|
| Adverse Event Reporting: During the Study | S. Eric Ceh | AUG 2009 |
|
|
| Conflict of Interest as a Disease | Norman M. Goldfarb | AUG 2009 |
|
|
| What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment | Robin Pierce | AUG 2009 |
|
|
| Transferring Subjects between Research Sites | Townsend N. Barnett, Jr. | AUG 2009 |
|
|
| Solving the Revenue Collection Problem for Clinical Research Sites | Norman M. Goldfarb | SEP 2009 |
|
|
| International Standards for Research Integrity: An Idea Whose Time has Come? | David Resnik | SEP 2009 |
|
|
| Should a Clinical Research Coordinator Be a Nurse? | Judy Katzen | SEP 2009 |
|
|
| Smart Clinical Research Protocols | Fredric J. Cohen | SEP 2009 |
|
|
| Subinvestigators | Norman M. Goldfarb | SEP 2009 |
|
|
| Study Closeout at Research Sites | Norman M. Goldfarb | OCT 2009 |
|
|
| Motivating Research Coordinators with a Career Path and Development Program | Jo Ann Broeckel Elrod | OCT 2009 |
|
|
| Seamless Designs in Adaptive Research | Michael Rosenberg | OCT 2009 |
|
|
| Drafting a Policy for Research Conflicts of Interest | Jeremy Stoloff | NOV 2009 |
|
|
| Delegation of Duties | Norman M. Goldfarb | NOV 2009 |
|
|
| Questions in Site Selection Questionnaires | Norman M. Goldfarb | NOV 2009 |
|
|
| Clinical Research Bullies | Norman M. Goldfarb | DEC 2009 |
|
|
| A New Standard for Medical Device Adverse Event Classification | Nancy J. Stark | DEC 2009 |
|
|
| What Parents Want: Pediatric Studies that Appeal to Parents and Meet Ethical Guidelines | Robert M. Jacobson | DEC 2009 |
|
|
| Stephen Barrett, MD on Medical Quackery | Norman M. Goldfarb | DEC 2009 |
|
|
| Research Misconduct Policies of Scientific Journals | David B. Resnik, Shyamal D. Peddada, and Winnon Brunson, Jr. | JAN 2010 |
|
|
| Research Involving Prisoners in Non-Prison Settings: FDA and OHRP Regulations | David Vulcano | JAN 2010 |
|
|
| Protocol Feasibility Process and Forms for Clinical Sites | Rachel Sheppard | FEB 2010 |
|
|
| The Response Shift Phenomenon in Clinical Trials | Steven McPhail and Terry Haines | FEB 2010 |
|
|
| Ten Ways to Recognize a Clinical Research Professional | Norman M. Goldfarb | APR 2010 |
|
|
| Training Requirements for Shipping Human Specimens by Air | David Creighton | MAY 2010 |
|
|
| Private Insurance Reimbursement for Routine Clinical Trial Costs | Stephanie B. Vasconcellos | MAY 2010 |
|
|
| Safe Transportation of Clinical Trial Samples | Lori A. Ball | MAY 2010 |
|
|
| Expanding a Site into Phase I Trials | Gary K. Zammit and Norman M. Goldfarb | JUN 2010 |
|
|
| Reporting Unanticipated Problems to IRBs | Norman M. Goldfarb | JUN 2010 |
|
|
| Transitioning to a New Research Coordinator | Ashrafunissa Janmohammad | JUL 2010 |
|
|
| Adverse Event Reporting and Treatment after the Study | S. Eric Ceh | SEP 2010 |
|
|
| An Ethical Model for International Clinical Research | Norman M. Goldfarb | SEP 2010 |
|
|
| Lifestyle Modification in Drug Clinical Trials | Mark Hochhauser | SEP 2010 |
|
|
| Clinical Study Project Plans | Laurie Halloran | SEP 2010 |
|
|
| Reducing Human Error in Checking Concomitant Medications | Mark Dale, Stephen Goundrey-Smith, Steve Higham and Andy Collinson | OCT 2010 |
|
|
| How CROs Can Earn the Sponsor’s Respect and Trust | Julie Stein | OCT 2010 |
|
|
| Study Drug Accountability | Paula Smailes | OCT 2010 |
|
|
| Dealing with Misconduct in Biomedical Research: A Review of the Problems and the Proposed Methods for Improvement | Malhar N. Kumar | NOV 2010 |
|
|
| Consent Forms: Let’s Get the Basics Right | Mark Hochhauser | NOV 2010 |
|
|
| Financial Disclosure by Investigators | Norman M. Goldfarb | NOV 2010 |
|
|
| Investigator Compensation by the Research Site | Norman M. Goldfarb | NOV 2010 |
|
|
| Don’t Cherry-Pick Study Subjects | Paul Latimer | DEC 2010 |
|
|
| The New Investigative Site: Take Nothing for Granted | Elizabeth Weeks-Rowe | DEC 2010 |
|
|
| Happy Holidays! | Norman M. Goldfarb | DEC 2010 |
|
|
| Biorepositories for Long-Term Preservation and Future Analysis | Catherine Michael | JAN 2011 |
|
|
| Keeping Device Study Costs under Control: Building a Realistic Budget | Nancy J. Stark | JAN 2011 |
|
|
| Writing Notes to File at the Study Site | Tatjana Markovic | JAN 2011 |
|
|
| Simple Language for Assent Forms | Stephanie Lowenhaupt | FEB 2011 |
|
|
| A New Standard for Medical Device Investigations | Nancy J. Stark | FEB 2011 |
|
|
| Driving the Performance of a Clinical Research Site with Metrics | Norman M. Goldfarb | FEB 2011 |
|
|
| An Introduction to Medicare Coverage Analysis for Drug Trials | Kathy Hammerhofer | MAR 2011 |
|
|
| Legally Authorized Representatives in Clinical Trials | Judy Katzen | MAR 2011 |
|
|
| Site Profiles | Shae Owens | MAR 2011 |
|
|
| Business Development for Clinical Trial Sites | Terence L. Webb | APR 2011 |
|
|
| Is This Study Exploitative? | Norman M. Goldfarb | APR 2011 |
|
|
| Thank You for Your Time | Norman M. Goldfarb | APR 2011 |
|
|
| Clinical Evaluation Reports for Medical Devices: What Do Notified Bodies Want? | Nancy J. Stark | MAY 2011 |
|
|
| Institutional Financial Conflicts of Interest in Clinical Research | Robert S. Bienkowski and Norman M. Goldfarb | MAY 2011 |
|
|
| Even Sunshine Causes Shadows: A Look at How the New “Transparency Act” May Affect Clinical Researchers | David Vulcano | JUN 2011 |
|
|
| Let the Games Begin | Greg Osgood | JUL 2011 |
|
|
| Study Registration Loopholes | Carleton Southworth | JUL 2011 |
|
|
| Monitoring with an Auditor’s Eye | Linda C. Rudolph | AUG 2011 |
|
|
| Solving the IRB “Community Member” Problem | Charlotte Coley | AUG 2011 |
|
|
| Constructive Site Audits | Gail Grant | AUG 2011 |
|
|
| Introduction to Drug Development and FDA Drug Approval Processes | Surabhi Sharma | AUG 2011 |
|
|
| Working with Pharmaceutical Companies on Investigator-Initiated Clinical Trials | Surabhi Sharma | AUG 2011 |
|
|
| Our Quirky Study Team | Joél Marie Barra | AUG 2011 |
|
|
| Site-Managed Advertising for Subject Recruitment | Kevin Ketels | OCT 2011 |
|
|
| Data Management in Device Studies | Nancy J. Stark | OCT 2011 |
|
|
| Degrees of De-identification of Clinical Research Data | Jeanne M. Mattern | NOV 2011 |
|
|
| Voluntary Withdrawal of Consent | Norman M. Goldfarb | NOV 2011 |
|
|
| How Will DEA Affect Your Clinical Study? | Terrance W. Woodworth | DEC 2011 |
|
|
| Happy Holidays to Our CRA Friends | Norman M. Goldfarb | DEC 2011 |
|
|
| The Three-Page Informed Consent Form | Norman M. Goldfarb | DEC 2011 |
|
|
| Why I am a Clinical Research Coordinator | Phalia McCorkle-Kester | DEC 2011 |
|
|
| Partnership Heresy | Ronald S. Waife | JAN 2012 |
|
|
| Clinical Trial Supply Fundamentals | Randy Schwemmin and Norman M. Goldfarb | FEB 2012 |
|
|
| Subject Recruitment Mailers | Terry Stubbs | FEB 2012 |
|
|
| Site Visit Follow-Up | Amy Adams and Rosanne Petros | FEB 2012 |
|
|
| Source Documents for Clinical Trial Visits | Paula Smailes | FEB 2012 |
|
|
| Adverse Event and Drug Coding in Clinical Research | Samina Qureshi | MAR 2012 |
|
|
| The Sponsor’s Role in Medicare Reimbursement for Clinical Trials | Beth DeLair and Kelly Willenberg | MAR 2012 |
|
|
| Sponsor Report Cards | Norman M. Goldfarb | APR 2012 |
|
|
| Steve Jobs, CRA: What Would Steve Do? | Eric Ceh | APR 2012 |
|
|
| Underestimating Regulatory Sophistication in Other Countries | Norman M. Goldfarb | APR 2012 |
|
|
| Boilerplate Provisions in Clinical Trial Agreements | Tara Cowell | MAY 2012 |
|
|
| The Foreign Corrupt Practices Act and Clinical Research | Darshan Kulkarni | MAY 2012 |
|
|
| Quality by Design: Manufacturing Has It Right | John R. Wilson, Jr. | MAY 2012 |
|
|
| Metrics for Research Administration Offices (Part 1) | Nathan Haines | JUN 2012 |
|
|
| Optimizing Sample Size | Carleton Southworth | JUN 2012 |
|
|
| Adverse Event Terminology | Norman M. Goldfarb | JUL 2012 |
|
|
| Amenities at Healthy Volunteer Clinical Research Facilities | Norman M. Goldfarb | JUL 2012 |
|
|
| Metrics for Research Administration Offices (Part 2) | Nathan Haines | JUL 2012 |
|
|
| Streamlining the Collection of Adverse Event Data | Cheryl Weaver | AUG 2012 |
|
|
| The Park Doctrine and Clinical Trials | Darshan Kulkarni | AUG 2012 |
|
|
| Working with Difficult Investigators | Rachel Garman and Norman M. Goldfarb | SEP 2012 |
|
|
| Clinical Research Fraud: The Case of the Errant Investigator | Barbara Burkott | SEP 2012 |
|
|
| Clinical Research at Small Sites | Gina Nesbit | SEP 2012 |
|
|
| Some Quality Food for Thought | John R. Wilson, Jr. | OCT 2012 |
|
|
| Rehearsing Sites for Successful Study Conduct | Norman M. Goldfarb | OCT 2012 |
|
|
| Site Monitor Feedback | Norman M. Goldfarb | OCT 2012 |
|
|
| Site Qualification Questions | Norman M. Goldfarb | OCT 2012 |
|
|
| eDiary Problems: Avoidance and Mitigation | John Lacombe | NOV 2012 |
|
|
| Introduction to Budget Development for NIH Grants | Jenna Lee | NOV 2012 |
|
|
| Operational Input from Investigators for Protocol Feasibility Assessment | Lisa Palladino Kim, Otis Johnson, and Brendan O’Neill | NOV 2012 |
|
|
| Rehearsing Sites for Successful Study Conduct | Norman M. Goldfarb | NOV 2012 |
|
|
| Happy Holidays to Our Investigator Friends | Gina Nesbit | DEC 2012 |
|
|
| Successful FDA Inspections at Investigative Sites for Clinical Trials of Drugs and Biologics | Swati Tendolkar | JAN 2013 |
|
|
| Moral Licensing | Norman M. Goldfarb | JAN 2013 |
|
|
| Risk-Based Monitoring Across Six Dimensions | Margaret F. Fay | JAN 2013 |
|
|
| Global Clinical Trial Liability Insurance | Frank Goudsmit | FEB 2013 |
|
|
| Regulatory Placemats: A Simple Solution to a Significant IRB Problem | David Vulcano | FEB 2013 |
|
|
| Surviving the Aftermath of an FDA Clinical Trial Inspection (Part 1) | Lee Truax-Bellows | MAR 2013 |
|
|
| Do the Best Hospitals Do the Most Clinical Research? | Norman M. Goldfarb | MAR 2013 |
|
|
| What to Do with External Safety Reports? | Robert S. Bienkowski and Barbara J. Broome | MAR 2013 |
|
|
| AcmeCRO Goes Public | Norman M. Goldfarb | APR 2013 |
|
|
| Subject Injury Risk Management for Research Sites | Norman M. Goldfarb | APR 2013 |
|
|
| Coercion and Undue Influence: The Worst Consent Ever? | Norman M. Goldfarb | APR 2013 |
|
|
| Surviving the Aftermath of an FDA Clinical Trial Inspection (Part 2) | Lee Truax-Bellows | JUN 2013 |
|
|
| Avoiding Common Pitfalls in Multinational Clinical Trials | Dan McDonald | JUL 2013 |
|
|
| Practical Strategies to Improve Informed Consent | David S. Festinger and Karen L. Dugosh | JUL 2013 |
|
|
| Effective Management of Patient Recruitment Organizations | Beth D. Harper | AUG 2013 |
|
|
| Financial Accruals for Clinical Trials – A Primer | Christopher Chan | SEP 2013 |
|
|
| Adaptive Monitoring: Risk-Based Monitoring and Beyond | Michael Rosenberg | SEP 2013 |
|
|
| When Is a Medical Record Not a Source Document? | Paul R Latimer | SEP 2013 |
|
|
| Clinical Study Data, Electronic Medical Records, and Privacy | Jeanne M. Mattern | OCT 2013 |
|
|
| Five Intellectual Property Loopholes in Clinical Trial Agreements | Michael Powers | OCT 2013 |
|
|
| All Global Clinical Studies Are Local | Vladimir Bogin | NOV 2013 |
|
|
| Study Subject Prescreening Strategies in a Hospital Cardiovascular Program | Angela DiSabatino and Andrea Squire | NOV 2013 |
|
|
| To SMQ or not to SMQ? | Samina Qureshi | NOV 2013 |
|
|
| Happy Holidays to Our Study Coordinator Friends | Norman M. Goldfarb | DEC 2013 |
|
|
| Defining Compliance, Serious Noncompliance, and Continuing Noncompliance in IRB Policies | Robert S Bienkowski | DEC 2013 |
|
|
| Choose to Succeed in Clinical Research | Suzanne J. Rose | JAN 2014 |
|
|
| Protecting Innovation and Trade Secrets with Non-Compete Agreements | Gregory A. Hendershott & Jennifer C. Berry | JAN 2014 |
|
|
| Oft-Negotiated CDA Terms | Stephen S. Broadhead, Jr. | FEB 2014 |
|
|
| Re-Consent Upon Reaching the Age of Majority: Ethical Issues | David B. Resnik | FEB 2014 |
|
|
| The Golden Age of Clinical Research Innovation | Norman M. Goldfarb | MAR 2014 |
|
|
| Indemnification in Clinical Trial Agreements | Michael Powers and Kelly Smith | MAR 2014 |
|
|
| Ten Subject Stipend Issues | David Vulcano | MAR 2014 |
|
|
| Integrating Clinical Research Sites in Mergers and Acquisitions | Sandra Albritton and Rhonda J. Paz | APR 2014 |
|
|
| Heer Health Clinic Announces Heer System for Patient-Centric Clinical Studies | Norman M. Goldfarb | APR 2014 |
|
|
| Evolution of a Robust Design Framework for Clinical Development | Kaushal Desai, Ian Fisher, Emma Witch, Laszlo Vasko, Christopher Miller, and Martin Simán | MAY 2014 |
|
|
| Clinical Research as a Learning Industry | Norman M. Goldfarb | MAY 2014 |
|
|
| Site Perspectives on Clinical Supply | Pat Larrabee, Samantha Carmichael, Marisa Co, Mary Costello, James Denmark, Mary Jo Lamberti, Diane Orino, Ana Sanseau, Kathy Stoddard, and Amy Musolino | MAY 2014 |
|
|
| Disclosing the Routine Costs of Participating in a Clinical Study | Tammy Cobaugh | JUN 2014 |
|
|
| Integrating the Clinical Research Activities of Physician Groups into Healthcare Systems | Marti Gardner and Rhonda Hoffman | JUL 2014 |
|
|
| The Risk of Not Managing Risk | John K. Hogan | JUL 2014 |
|
|
| Who Owns My Intellectual Property? | Darshan Kulkarni and McKenzie Noblitt Baker | AUG 2014 |
|
|
| Regulatory Myths in Clinical Research | Brian A. Gladue | SEP 2014 |
|
|
| Quality Risk Management in Clinical Trials | Stacy Levy and Donna Dorozinsky | SEP 2014 |
|
|
| Introduction to Biospecimens | Martha Weinar | OCT 2014 |
|
|
| The Eight Elements of Quality Management | Gary C. Cseko | OCT 2014 |
|
|
| Payments to Study Participants | Norman M. Goldfarb | OCT 2014 |
|
|
| A Statistical Approach to Risk-Based Monitoring | Marc Buyse | NOV 2014 |
|
|
| Lessons Learned from 20 Years as a Site Monitor | S. Eric Ceh | NOV 2014 |
|
|
| Quality Agreements: Contractual Commitments by CROs to Deliver High-Quality Work | Tom McGrady and Susan Callery-D’Amico | NOV 2014 |
|
|
| Consent Form Humor | Mark Hochhauser | DEC 2014 |
|
|
| Happy Holidays to Our Study Manager Friends | Marc Buyse | DEC 2014 |
|
|
| Five Steps for Improving Processes in Clinical Trials | John R. Wilson, Jr. | JAN 2015 |
|
|
| Site Contracting and IRB Review Processes: Parallel or Serial? | Norman M. Goldfarb | FEB 2015 |
|
|
| Is This Confidential? | By Jeff Qureshi and Norman M. Goldfarb | MAR 2015 |
|
|
| DHS and DHHS to Merge | Norman M. Goldfarb | APR 2015 |
|
|
| The Problem with State “Right to Try” Legislation | David Vulcano and Norman M. Goldfarb | APR 2015 |
|
|
| More Regulatory Myths in Clinical Research | Brian A. Gladue | MAY 2015 |
|
|
| Quality by Design in Clinical Research | Vatche Bartekian | MAY 2015 |
|
|
| Thirteen Questions for IRBs to Ask About Risk Disclosure | Thirteen Questions for IRBs to Ask About Risk Disclosure | MAY 2015 |
|
|
| Monitoring with an Auditing Mindset | Brandy Chittester | JUN 2015 |
|
|
| Local IRB Collaboration in Central IRB Reviews | Joseph E. Andrews, Jr. and J. Brian Moore | JUL 2015 |
|
|
| Lessons from the Markingson Controversy | Norman M. Goldfarb | AUG 2015 |
|
|
| Scientific Review of Human Subjects Research | David B. Resnik | AUG 2015 |
|
|
| Wasteful Clinical Research Processes | Norman M. Goldfarb | AUG 2015 |
|
|
| FDA Medical Device Regulations vs. ISO 14155 | Shawn Kennedy | SEP 2015 |
|
|
| Sixteen Red Flags for the IRB | Dennis J. Mazur and Norman M. Goldfarb | SEP 2015 |
|
|
| Three Steps to Recruiting Study Participants through Your Website | Rick E. Greenfield | SEP 2015 |
|
|
| Disbursing Cash and Cash-Equivalent Incentives for Study Participants | Piotr T. Dybas and David W. Allen | OCT 2015 |
|
|
| A Code of Ethics for Institutional Review Boards | Norman M. Goldfarb | OCT 2015 |
|
|
| Group Recruitment to Improve Clinical Study Enrollment and Retention | Sam Atkinson, Steve Kepes, and Steve Rowe | NOV 2015 |
|
|
| Using Sunshine Act Data for Competitive Analysis and Other Purposes | Norman M. Goldfarb | NOV 2015 |
|
|
| Happy Holidays to Our Patient Recruitment Friends | Norman M. Goldfarb | DEC 2015 |
|
|
| Twelve Questions for an IRB to Ask When Assessing Risk vs. Benefit in a Research Study Proposal | Dennis J. Mazur and Norman M. Goldfarb | DEC 2015 |
|
|
| Dissecting Electronic Signatures for the Life Sciences | Robert Finamore and John Harris | JAN 2016 |
|
|
| How Can IRBs Help Investigators with their Applications? | Dennis J. Mazur and Norman M. Goldfarb | JAN 2016 |
|
|
| Even More Regulatory Myths in Clinical Research | Parker Nolen | JAN 2016 |
|
|
| Four Fundamental Issues An IRB Must Decide When Reviewing a Clinical Research Study | Dennis J. Mazur and Norman M. Goldfarb | FEB 2016 |
|
|
| Study Nicknames | Norman M. Goldfarb | FEB 2016 |
|
|
| Twelve Signs that It’s Time to Change Your Business Process | Terry Bird | FEB 2016 |
|
|
| Clinical Research Progress Notes | S. Eric Ceh | MAR 2016 |
|
|
| Twelve Attributes of a Successful Community Research Site | Manda Materne and Mary Frances Dobry | MAR 2016 |
|
|
| Scientists Demonstrate that Visual Exposure to Color Modifies Neurological Effects of Coffee | Norman M. Goldfarb | APR 2016 |
|
|
| Accelerating Clinical Trial Agreement Negotiations through Effective Communications | Erica L. McKeon and Matthew G. Drapeau | APR 2016 |
|
|
| What Is Patient-Centricity? | Norman M. Goldfarb | APR 2016 |
|
|
| Informed Consent for New Investigators | Norman M. Goldfarb | JUN 2016 |
|
|
| Physician Referrals: The Power of the Physician/Patient Partnership | Sarah Mandracchia | JUN 2016 |
|
|
| Seventeen Questions an IRB Should Ask About a Research Site’s Communication System | Dennis J. Mazur and Norman M. Goldfarb | JUL 2016 |
|
|
| FMV and the Market Failure in Clinical Research | Norman M. Goldfarb | JUL 2016 |
|
|
| How to Negotiate Study Budgets | Norman M. Goldfarb | AUG 2016 |
|
|
| Yet More Regulatory Myths | R. Bert Wilkins | AUG 2016 |
|
|
| Informing vs. Persuading in the Consent Process | Dennis J. Mazur and Norman M. Goldfarb | AUG 2016 |
|
|
| Investigator Compensation: Motivation vs. Regulatory Compliance | Payal Cramer | SEP 2016 |
|
|
| Seven Questions about Informed Consent for Clinical Studies of Genetic Tests | Dennis J. Mazur and Norman M. Goldfarb | SEP 2016 |
|
|
| Developing an Investigator Compensation Plan | Matthew Gibson | SEP 2016 |
|
|
| Case Report Form Mapping to Ensure Data Integrity | Glenda M. Guest and Norman Goldfarb | OCT 2016 |
|
|
| Eight Questions for an IRB to Ask About Post-Study Risks | Dennis J. Mazur and Norman M. Goldfarb | OCT 2016 |
|
|
| The Cost to Sites of Remote Monitoring | Michael Kassin and Norman M. Goldfarb | OCT 2016 |
|
|
| TMF Trackers: Powering Your TMF for Inspection Readiness | Brandon Butler and Sholeh Ehdaivand | OCT 2016 |
|
|
| Cold Chain Planning for Clinical Studies of Regenerative Medicines | Mark W. Sawicki | NOV 2016 |
|
|
| 33 Questions an IRB Should Ask about the Research Informed Consent Process | Dennis J. Mazur and Norman M. Goldfarb | NOV 2016 |
|
|
| How to Know When You’re Keeping Your Customers Satisfied | Eric Hayashi | NOV 2016 |
|
|
| An Organizing Principle for Innovation in Clinical Research | Norman M. Goldfarb | DEC 2016 |
|
|
| Happy Holidays to Our IRB Friends | Norman M. Goldfarb | DEC 2016 |
|
|
| Supplementing Clinical Development with a Managed Access Program | Dan Wasserstrom | JAN 2017 |
|
|
| 20 Questions an IRB Can Ask to Assess the Risk of Therapeutic Misconception | Dennis J. Mazur and Norman M. Goldfarb | JAN 2017 |
|
|
| 15 Questions for an IRB to Ask About Privacy | Dennis J. Mazur and Norman M. Goldfarb | FEB 2017 |
|
|
| 40 Techniques for Increasing the Likelihood of Obtaining Consent from a Study Participant | Norman M. Goldfarb | FEB 2017 |
|
|
| Should Informed Consent Forms Have Black-Box Warnings? | Dennis J. Mazur and Norman M. Goldfarb | MAR 2017 |
|
|
| Patient Engagement in Clinical Studies | Norman M. Goldfarb | MAR 2017 |
|
|
| Material Transfer and Data Use Agreements | Nanci K. Carr, Irene Shin, and Steven Maier | MAR 2017 |
|
|
| Informed Consent Form Statements of Benefit | Erica Heath and Norman M. Goldfarb | APR 2017 |
|
|
| Executive Order: Affordable Prescription Drugs for America | Norman M. Goldfarb | APR 2017 |
|
|
| Institutional Officials and the Price of Compliance | Suzanne M. Rivera and Lois Brako | APR 2017 |
|
|
| An Experiment with Lean Methods in Clinical Research | Andrew Snyder and Virginia Cosgriff | APR 2017 |
|
|
| The Patient Experience in Clinical Studies | Norman M. Goldfarb | MAY 2017 |
|
|
| Research and Patient Privacy in the 21st Century: HIPAA and Beyond | Rachel Abramovitz | MAY 2017 |
|
|
| Investigative Sites Speak Out About Remote Monitoring | Norman M. Goldfarb | MAY 2017 |
|
|
| Ten Questions for an IRB to Ask About the Science behind a Protocol | Dennis J. Mazur and Norman M. Goldfarb | MAY 2017 |
|
|
| Ten Tips to Turn your Clinical Research CV into an Interview | Theodora Savlovschi-Wicks | JUN 2017 |
|
|
| Effort-Based Salary Support for PI Oversight Charges | Anita Bowler | JUL 2017 |
|
|
| Clinical Research vs. Clinical Care | Andrew Snyder | JUL 2017 |
|
|
| User Acceptance Testing of Clinical Databases | Dawn Edgerton | JUL 2017 |
|
|
| eSource in the Age of Complexity | Raymond Nomizu | AUG 2017 |
|
|
| Investigative Site Files and Trial Master Files Should Talk to Each Other | Betsy Fallen, Sholeh Ehdaivand, Norman M. Goldfarb, and Amy Lounsbury | AUG 2017 |
|
|
| Regulatory File Table of Contents | Leanne Tran | AUG 2017 |
|
|
| Who Owns the Data from a Clinical Study? | Leanne Tran | AUG 2017 |
|
|
| Eight Questions to Ask Your Equipment Calibration Service Provider | Robin Salter | SEP 2017 |
|
|
| Still More Regulatory Myths | Rebecca Rogers | SEP 2017 |
|
|
| Clinical Research with Controlled Substances | Emmelyn Kim and Ji-Eun Kim | OCT 2017 |
|
|
| Nine Questions for an IRB to Ask About Clinical Studies That Involve Genetic Testing | Dennis J. Mazur and Norman M. Goldfarb | OCT 2017 |
|
|
| Key Elements for Implementing Clinical Research as a Care Option | Kristin Kinlaw | NOV 2017 |
|
|
| The Power of Questions: A Secret to Effective Communication | Mitchell Goozé | NOV 2017 |
|
|
| Promoting a Culture of Excellence in the Clinical Research Site Community | Norman M. Goldfarb | DEC 2017 |
|
|
| Happy Holidays to Our Clinical Scientist Friends | Norman M. Goldfarb | DEC 2017 |
|
|
| What is Fair Market Value? | Norman M. Goldfarb | DEC 2017 |
|
|
| Basic Concepts for Informed Consent | Dennis J. Mazur and Norman M. Goldfarb | JAN 2018 |
|
|
| Integrating Human Factors/Usability Engineering and Usability Testing into Medical Device Total Product Life Cycle | Kathi Durdon | JAN 2018 |
|
|
| Ancillary Service Provider Agreements in Clinical Research | Chris Beardmore and Martin Walsh | FEB 2018 |
|
|
| 16 Do’s and Don’ts for Describing the Risks in a Clinical Study | Dennis J. Mazur and Norman M. Goldfarb | MAR 2018 |
|
|
| Solving the Problem of Slow Payments to Sites | Laura Hilty, Shaun H. Williams, and Norman M. Goldfarb | MAR 2018 |
|
|
| A/B Testing for Digital Audience Optimization for Clinical Study Enrollment | Sandra Shpilberg | APR 2018 |
|
|
| President Sends Drugs for America Act to Congress | Norman M. Goldfarb | APR 2018 |
|
|
| Email Is in the Eye of the Beholder | Janet Lewis and Norman M. Goldfarb | MAY 2018 |
|
|
| The Big Meld: The Future Integration of Clinical Research and Clinical Care | Norman M. Goldfarb | MAY 2018 |
|
|
| My Responsibilities as a Clinical Study Participant | Kiran Bahrus and Norman M. Goldfarb | MAY 2018 |
|
|
| Managed Access Program Synergies with Clinical Studies | Dan Wasserstrom | JUN 2018 |
|
|
| Trust as a Principle for Ethical Decision-Making in Research with Human Subjects | David B. Resnik | JUN 2018 |
|
|
| BYOD: Consumer Mobile Devices in Clinical Research | Lee Truax-Bellows | JUL 2018 |
|
|
| Causality Determination in Pharmacovigilance | Sameer Thapar | JUL 2018 |
|
|
| In Vitro Diagnostic Test Development | Lyssa Friedman | JUL 2018 |
|
|
| Therapeutic Misconception, Unrealistic Optimism, and Hope in Phase I Oncology Trials | David B. Resnik | AUG 2018 |
|
|
| Right to Try: It’s More Complicated Than You Think | David Vulcano | AUG 2018 |
|
|
| My Experience as a Remote Site Monitor | Susan M. Radtke | SEP 2018 |
|
|
| How Do Sites Like the Electronic Systems Provided by Sponsors? | Norman M. Goldfarb | SEP 2018 |
|
|
| How to Choose a CRO, the Most Important Decision in a Clinical Study | Eric Distad | OCT 2018 |
|
|
| What Constitutes a Site Quality Management System? | Wade Strzinek, Ali Sonel, and Norman M. Goldfarb | OCT 2018 |
|
|
| Investigative Site Files and Trial Master Files Should Talk to Each Other | Sholeh Ehdaivand and Norman M. Goldfarb | NOV 2018 |
|
|
| Happy Holidays to Our Information Technology Friends | Sholeh Ehdaivand and Norman M. Goldfarb | DEC 2018 |
|
|
| If Research is Therapeutic, Where’s the Misconception? | Jim Gearhart | DEC 2018 |
|
|
| Why Fair Market Value Is Not One Number | Norman M. Goldfarb | JAN 2019 |
|
|
| Why We Need to Keep the Term “Research Subject” in Our Research Ethics Vocabulary | Elisa A. Hurley | FEB 2019 |
|
|
| Comparing Methods of Identifying High-Risk Sites | Rosanne Petros, Agata Leszczynska, Radim Klapka, Bonnie Bushnell, and Maria Weber | FEB 2019 |
|
|
| The European Union General Data Protection Regulation (GDPR) | Rupal V. Vora | MAR 2019 |
|
|
| Everyone Has a Story | Norman M. Goldfarb | MAR 2019 |
|
|
| Fear and Longing in Clinical Research | Norman M. Goldfarb | APR 2019 |
|
|
| Reducing Drug Development Costs with Protocol Cost Savings Analysis (PCSA) | Nicolas Cindric | MAY 2019 |
|
|
| My First Clinical Research Job | Norman M. Goldfarb | JUN 2019 |
|
|
| Quality by Design in Clinical Research | Norman M. Goldfarb | JUN 2019 |
|
|
| Are Payments to Human Research Subjects Ethically Suspect? | David B. Resnik | JUN 2019 |
|
|
| Get a Handle on Your Research Site’s Technology | Norman M. Goldfarb | AUG 2019 |
|
|
| Shannon’s Story | John Barry, her father | AUG 2019 |
|
|
| Active Listening in Informed Consent Discussions | Norman M. Goldfarb | SEP 2019 |
|
|
| So You Want a New Computer System? | Erika Stevens and Brian Chappell | SEP 2019 |
|
|
| Is Your Site Financially Healthy? | Ari Axelrod | OCT 2019 |
|
|
| “Patient Centricity” Must Be More than a Cliché: A Letter to the Clinical Research Community | Donald A. Deieso | OCT 2019 |
|
|
| 12 Questions to Ask an eClinical Software Vendor About Its Open API | Blake Adams | NOV 2019 |
|
|
| The Research Site’s Role in Supporting Patient Centricity with eConsent | Neetu Pundir | NOV 2019 |
|
|
| What do Sites and Sponsors/CROs Really Want from Each Other? | Norman M. Goldfarb | DEC 2019 |
|
|
| Norman M. Goldfarb | Happy Holidays to Our Pharmacovigilance Friends | DEC 2019 |
|
|
| The Challenges of Direct-to-Patient Logistics | Mike Sweeney | JAN 2020 |
|
|
| Reflections on the Belmont Report at 40 | Elisa A. Hurley | FEB 2020 |
|
|
| When Can a Study Sponsor Pay Different Prices to Different Sites and Not Violate Fair-Market-Value Principles? | Norman M. Goldfarb | FEB 2020 |
|
|
| Does the Clinical Research Enterprise Have a Burnout Problem? | Norman M. Goldfarb | MAR 2020 |
|
|
| COVID-19 News You Won’t Believe | Norman M. Goldfarb | APR 2020 |
|
|
| The Importance of Capturing Raw Sensor Data for Clinical Studies | Geoffrey Gill | MAY 2020 |
|
|
| Clinical Trial Transparency | Darshan Kulkarni | MAY 2020 |
|
|
| 11 Questions About Confidential Disclosure Agreements in Clinical Research | Kelly L. Smith | JUN 2020 |
|
|
| The Clinical Research Team at a Community Hospital: Essential Now and Essential After the Pandemic | Suzanne J. Rose | JUN 2020 |
|
|
| Do You Have a Great Site Monitor? Ask These 10 Questions to Find Out | Mindy A. Ditch | JUL 2020 |
|
|
| Common Challenges in Launching an Investigator-Initiated Multisite Study | Krista K. Vermillion | JUL 2020 |
|
|
| Tales from the Field: Site Monitors Tell Their Stories | Eric Ceh | AUG 2020 |
|
|
| The Centricity of Decentralization | Alison Holland | SEP 2020 |
|
|
| Building a Quality Culture Based on Ethics | Tracy Morrison | SEP 2020 |
|
|
| The 10 Essential Steps for Crisis Management | Norman M. Goldfarb | OCT 2020 |
|
|
| 10 Steps to Promote Diversity and Inclusion in Your Next Clinical Study | Norman M. Goldfarb | OCT 2020 |
|
|
| Choose Studies Wisely to Increase Your Site’s Clinical Research Capacity | Norman M. Goldfarb | OCT 2020 |
|
|
| Can We Automate Clinical Research? | Norman M. Goldfarb | NOV 2020 |
|
|
| Reverse Mentoring: How Senior Team Members Can Learn from Junior Team Members | John R. Nocero, Jessica Craig, Danielle Kroft and Danielle Greenidge | NOV 2020 |
|
|
| Data-Driven Trial Feasibility Analysis for Study Sponsors | Jane Fang | DEC 2020 |
|
|
| Streamlining Study Startups with Master Price Lists | Tina Marie Bowdish | DEC 2020 |
|
|
| Social Justice in Clinical Research | Norman M. Goldfarb | JAN 2021 |
|
|
| Where Do You Think You’re Going? Strategic Planning for Clinical Research Sites | Jill Heinz and Norman M. Goldfarb | JAN 2021 |
|
|
| How to Use Financial Statements to Manage Your Site | David G. Rossi | FEB 2021 |
|
|
| Medical Monitoring of Clinical Research Studies | Gerald L. Klein, Peter C. Johnson, and Roger Morgan | FEB 2021 |
|
|
| Justice in Research: Reflections on the Lessons of 2020 | Elisa A. Hurley | MAR 2021 |
|
|
| Is It Time to Sell Your Research Business? | Nicolas Cindric | MAR 2021 |
|
|
| Five Critical Investigator-Initiated Clinical Trial Agreement Clauses | Tara Cowell and Christina Stanger | APR 2021 |
|
|
| A Proven Strategy for Rapid CTA Negotiations | Robert T. King | APR 2021 |
|
|
| Messaging in Clinical Research Marketing Communications | Norman M. Goldfarb | MAY 2021 |
|
|
| Ownership Rights of Patentable Inventions in Clinical Studies and a Review of MAGI’s Clinical Trial Agreement Template | Shahnam Sharareh | MAY 2021 |
|
|
| 12 Essential Ingredients for Successful Clinical Research Supplier Audits | Chuck Crumpton | JUN 2021 |
|
|
| Achieving Robust GCP Compliance with ISO 9001 | Fernando Geijo, Merce Guilera and Xavier Ruiz | JUN 2021 |
|
|
| Standards of Evidence for IRB Decision-Making | David B. Resnik | JUL 2021 |
|
|
| An Introduction to Medicare Coverage Analysis | Sachit Verma | JUL 2021 |
|
|
| Weaponizing (and Disarming) Ambiguous Contract Language in Clinical Trial Agreements | Phil Reed Boyce | AUG 2021 |
|
|
| Supply Chain Cybersecurity in Clinical Research | Rebecca Rakoski | AUG 2021 |
|
|
| Clinical Trial Patient Recruitment Targeting in Facebook Advertising | Ross Jackson | SEP 2021 |
|
|
| Sample Size Re-Estimation | David R. Bristol | SEP 2021 |
|
|
| Streamlining the Study Feasibility Review Process at an Academic Medical Center | Holly Jones | OCT 2021 |
|
|
| Release Control and Empower Your Teams: The Servant Leadership Model | Steve Chriscoe | OCT 2021 |
|
|
| Degrees of Delegation in Clinical Research | Norman M. Goldfarb | NOV 2021 |
|
|
| Dealing with Problematic Comments on Clinical Study Facebook Ads | Ross Jackson | NOV 2021 |
|
|
| Information Technology Evolution at Clinical Research Sites | Norman M. Goldfarb | DEC 2021 |
|
|
| Physician-Investigator Compensation | Suzanne Rose | DEC 2021 |
|
|
| A Systematic Approach to Protocol Deviation Management at the Clinical Research Site | Mindy Ditch | JAN 2022 |
|
|
| Reengineer Your Clinical Research Site Processes | Jill Heinz | JAN 2022 |
|
|
| How to Be Heard Loud and Clear in a Complex Organization | Kristy Averette | MAR 2022 |
|
|
| The Slippery Slope into Research Misconduct: Research Records | Shelley Bizila and John R. Baumann | MAR 2022 |
|
|
| Key Concepts in Financial Accruals for Clinical Trials | Chris Chan | APR 2022 |
|
|
| Implementation of an Internal Quality Improvement Program: One Team’s Journey | Leslie Greenberg and Charmaine McKie | APR 2022 |
|
|
