Training providers meeting the GCP criteria set out in the guidelines are added to a list of mutually recognized providers. The Clinical Research Network has recently been added to this list. Now, when a study is placed at a site in the NHS, if the Principal Investigator and the research team have completed GCP training provided by the Clinical Research Network, they will not be required to undertake further company-specific GCP training. This will help to streamline study set-up and allow research teams to focus on other important set-up activities such as pre-screening patients.
The National Institute for Health Research (NIHR), under the NHS, Clinical Research Network’s Good Clinical Practice (GCP) training has been added to TransCelerate's list of programs mutually recognized by member companies. TransCelerate members, (which includes companies such as GSK, Pfizer and Roche), have developed guidelines for GCP training standards for research teams – those medical, nursing and clinical support staff delivering the clinical research studies.
Training providers meeting the GCP criteria set out in the guidelines are added to a list of mutually recognized providers. The Clinical Research Network has recently been added to this list. Now, when a study is placed at a site in the NHS, if the Principal Investigator and the research team have completed GCP training provided by the Clinical Research Network, they will not be required to undertake further company-specific GCP training. This will help to streamline study set-up and allow research teams to focus on other important set-up activities such as pre-screening patients.
The full release is located here.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.