During this time, five devices were used, ie, Ancure, AneuRx, Excluder, Talent, and Zenith, and six device-specific groups were analyzed; the Zenith group was subdivided into those placed as part of the multicenter trial (Zenith-MCT) and those under a sponsor-investigator investigational device exemption trial (Zenith-SIT).
CDC sponsored ARSN investigators from Indonesia, Taiwan, Vietnam, and Korea to train in Atlanta, and as a result, these sites have initiated genotyping of specimens from surveillance in these countries as of mid-2003.
These include institutional review boards (IRBs), standard operating procedures (SOPs), sites, sponsors, investigators, and patients.
Clinical trial sponsors, investigators and participants generally plan for a clinical trial to continue until scheduled completion.
Less familiar design methods incorporating these methodological features might be off-putting for sponsors, investigators, and reviewers.
Participants included sponsors, investigators, research ethics committee members and community representatives working in the fields of HIV/AIDS, TB and malaria vaccine research.
The value of cooperative relations needs more emphasis in this field given that sponsors, investigators and monitors are jointly responsible for ensuring that research protects human rights and produces reliable data, which can improve human health.
While ethics review committees can give oversight, only an active and transparent partnership between the research sponsor, investigators and the community can allow for effective on-going governance [ 1].
This reasoning provides the underpinning for the "fair benefits" model, which holds that exploitation can be avoided by ensuring a fair distribution of the benefits agreed upon by sponsors, investigators and the population at risk of exploitation [ 12, 13].
According to a stratified randomisation scheme (using a computerised list maintained by the sponsor), investigators assigned patients in a 2 : 1 ratio to treatment with CDDP/epi gel or placebo gel, within stratum I (target tumour volume <5 cm) or stratum II (target tumour volume >5 but ⩽20 cm).
For some investigator initiated trials, the principal investigator can be considered to be a "sponsor-investigator" who assumes both sponsor and investigator roles.
