Sentences with phrase «trials studies ensuring»

Not exact matches

Ghana's Ensure Mothers and Babies Regular Access to Care (EMBRACE) programme: study protocol for a cluster - randomised controlled trial

We urge the adoption of policies that ensure opportunities for people to participate in research studies and clinical trials without fear that the information generated by their participation will be inappropriately disclosed and adversely affect their health insurance status or that of their families, either as individuals or as members of a particular group.

«Enrolling only those likely to develop specific disease endpoints can reduce the number of people needing study and ensure the trial achieves an optimal mix of patients.»

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

Rather than wait for the results of that study, Reiman says that he and his colleagues decided to conduct the two trials simultaneously to ensure that any positive results from the Colombian study can be quickly tested into a more representative population — drugs that work for people with early - onset Alzheimer's might not necessarily help those with late - onset Alzheimer's, he says.

The GP practices were involved in ensuring the study not only had access to specific COPD patients but also that the usual clinical care provided by the practices was built into the trials — the study was therefore rooted in a real clinical environment unlike tradition efficacy trial model.

The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt - Ingram Cancer Center meet peer - reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients.

In accordance with the Cancer Center's Data and Safety Monitoring Plan (DSMP), internal compliance audits of interventional cancer trials are performed by the audit staff to ensure the conduct and integrity of the study are of the highest quality and that all trials adhere to regulatory requirements.

In 2009, The Clinical Trials Network (CTN) Scanner Validation Program was established to ensure baseline common quality control metrics for PET scanners used in multi-center studies.

The participants were required to maintain a dietary record 48 hours before each experimental trial to ensure consistency throughout the study.

While paitents are enrolled in a clinical trial, visits are typically coordinated by the BBVCTO staff, and efforts are made to ensure that quality of life is maintained or enhanced during the study.

All clinical trial protocols are reviewed by two separate review boards to ensure that the studies are well - designed, risks are mitigated and there is a reasonable likelihood of a similar or better outcome compared to current standards of veterinary care.

• Identify potential clinical study subjects by reviewing existing health information based on inclusion criteria • Interview potential subjects to determine their suitability for study trials • Carry out informed consent processes by assisting with registration information and records management • Ascertain that established clinical study protocols are implemented and maintain protocol integrity • Monitor participants» status by ensuring their safety and educate clinical staff on outcomes and expectations

PROFESSIONAL SUMMARY * 18 years of experience in data management * Leading data management staff in support of startup, conduct and close out including the largest cardiovascular outcomes trial in the industry * Managing several direct reports and leading large teams for both study project work in multiple therapy areas and initiatives for operational efficiency * Managing departmental resources, budgets and goals to ensure success * Providing expertise for global filings including preparatio...

Nurse Researcher Penn Medicine, Hampton, GA 10/2012 — Present • Provide and coordinate clinical care for patients involved in clinical research studies • Ascertain accuracy of data collection and data recording, and handle correlating follow - up • Schedule evaluation screenings and ensure that all participant are made physically and mentally ready for them • Provide patient participants with information on what to expect during clinical trials • Handle administration of investigational drugs, and handle detailed clinical assessments • Study chronic and acute diseases and disorders, and assist in developing new treatment plans • Assist in testing new treatments and medications that may change the way diseases and disorders are perceived • Compile clinical data and review and assess it for reporting purposes

Directed design, implementation and monitoring of clinical trials, preparation of INDs and periodic study reports for New Drug Applications, and ensured (GCP) was maintained.

We addressed some of the prior criticisms of EBT research by ensuring that (1) participants and study context were clinically representative, (2) there were no systematic differences in clinician competence across conditions (ie, all clinicians were randomly assigned), and (3) the sample would include the ethnic diversity that critics have found insufficient in the randomized controlled trial literature.17 - 20 Accordingly, we obtained samples from outpatient treatment programs that served the general public across a broad demographic and income range, we included only youths whose families sought treatment (ie, no recruiting or advertising), all treatment was provided by professional clinicians employed in the participating programs, and all treatment was provided in those programs (ie, not in university laboratory clinics).