Type of Clinical Research Covered. 2.1 These Guidelines apply to injury caused to patients involved in Phase II and Phase III trials, that is to say, patients under treatment and surveillance (usually in hospital) and suffering from the ailment which the medicinal product under trial is intended but for which a product licence does not exist or does not authorise supply for administration under the conditions of the trial.
Appears in 40 contracts
Samples: Tripartite Clinical Trial Agreement, Tripartite Clinical Trial Agreement, www.ccra.org.uk
Type of Clinical Research Covered. 2.1 These Guidelines apply to injury caused to patients involved in Phase II and Phase III trials, that is to say, patients under treatment and surveillance (usually in hospital) and suffering from the ailment which the medicinal product under trial is intended to treat but for which a product licence does not exist or does not authorise supply for administration under the conditions of the trial.
Appears in 7 contracts
Samples: Agreement (Monopar Therapeutics), Agreement (Monopar Therapeutics), Agreement (Monopar Therapeutics)
Type of Clinical Research Covered. 2.1 These Guidelines apply to injury caused to patients involved in Phase II and Phase III trials, that is to say, patients under treatment and surveillance (usually in hospital) and suffering from the ailment which the medicinal product under trial is intended to treat [Sponsor’s Protocol Reference Number], [Name of Site Principa1l Investigator] NHS-ABPI-BIA model Clinical Trial Agreement 2011 -– England – (DRAFT revision 2015 v0.4) but for which a product licence does not exist or does not authorise supply for administration under the conditions of the trial.
Appears in 1 contract
Samples: s3.eu-west-2.amazonaws.com