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News

New drug halves previously untreatable migraine attacks

04.19 2018.

A new compound, called erenumab, was found to be successful in treating migraines for which other treatments had previously failed. Details

IRBs Play Waiting Game with Revised Common Rule Implementation

04.18 2018.

Clinical Researcher—April 2018 (Volume 32, Issue 4) SPECIAL FEATURE Matthew Harrington [DOI: 10.14524/CR-18-4022]   Sometimes it pays to procrastinate. Institutional review boards (IRBs) that put off the work needed to comply with the revised Common Rule got a reprieve in January when compliance was delayed by six months.1 Just two days before the new rule […] Details

An IRB Perspective on Improving Informed Consent

04.18 2018.

Clinical Researcher—April 2018 (Volume 32, Issue 4) PEER REVIEWED Julie Blasingim, MBA, CIP; Sandra “SAM” Sather, MS, BSN, RN, CCRC, CCRA [DOI: 10.14524/CR-18-0003]   The informed consent process is essential to the ethical conduct of research on new medicinal products, therapies, and approaches to improving healthcare. The investigator can use various tools to optimize this […] Details

Study Start-Up Obstacles at an Academic Medical Center and How to Overcome Them

04.18 2018.

Clinical Researcher—April 2018 (Volume 32, Issue 4) PEER REVIEWED Julie Agriesti, CCRC; Paula Smailes, RN, MSN, CCRC, CCRP [DOI: 10.14524/CR-17-0026]   Few clinical trials are lucky enough to experience no start-up obstacles at an academic medical center (AMC). More often than not, these sites have a multitude of issues to overcome getting a study off […] Details

ICH E6(R2) and Data Integrity: Four Key Principles

04.18 2018.

Clinical Researcher—April 2018 (Volume 32, Number 4) ICH IN FOCUS Michael Rutherford, MS [DOI: 10.14524/CR-18-4021]   A few months prior to the release of the updated International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)),1 three draft guidance documents on the topic of “Data Integrity” and an explanatory Q&A document were published […] Details

Spring into ACRP 2018

04.18 2018.

Clinical Researcher—April 2018 (Volume 32, Issue 4) CHAIR’S MESSAGE Kathryn Kimmel, CCRC, CCRA, ACRP-CP, FACRP [DOI: 10.14524/CR-18-4023]   Spring greetings! As we enter a new season and look forward to an awakening of the Earth here in North America, my thoughts turn to our ACRP 2018 annual meeting, which runs April 27–30 at the Gaylord […] Details