When Should The Contractual Agreement Between The Sponsor And The Investigator Be Signed
Investigators should provide PS with a copy of the draft Clinical Trial Agreement (CTA), protocol and company contact as soon as possible. If a framework agreement already exists between the sponsor and the University of California, the negotiation process is usually accelerated. IRB approval is not required to submit the proposal to the PS and begin contract negotiations. Unless otherwise agreed with the inspection team, data must be collected in the groups defined below – each is presented in a different Excel spreadsheet. The columns „Study Location ID”, „Subject ID” and „Treatment Group” and, if applicable, „Visit ID” and/or „Visit Date” must be included in all tables. Some data collections may – depending on experience – belong to different groups, e.g. „vital signs/physical examination” usually belongs to the safety dataset; However, in a study on hypertension, this is probably an efficacy parameter. If in doubt, please ask the lead inspector: the acceptable time and frequency of acceptance for each study should be defined and justified by the sponsor and should be determined by the sponsor based on risk. The sponsor should consider the risks specific to the study and provide a rationale for the risk-based approach.
The types of data entered, the non-current data, the importance of the data, the data for analysis, the duration of the study and the sponsor`s decision based on the data entered, including the timing of these decisions, shall be taken into account. 4.2.5 The investigator shall be responsible for supervising any person or party to whom he delegates audit-related tasks and functions performed at the test site. The sponsoring company and the beneficial owner of the study drug or device, if an intermediary is involved, shall agree to indemnify and hold harmless the Foundation, investigator, agents, agents and employees from and against all liabilities, claims, acts or actions for personal injury or death arising out of the administration of the study drug or procedures performed in accordance with the protocol. including, but not limited to, the use of the study results by the sponsoring company. The Foundation shall only exempt the sponsor for negligent activities. Framework agreements are agreements that embody the agreed terms of a fundamental relationship between RFSUNY and a sponsor. As soon as a framework agreement is in place, an „addendum”, a „work order” or a „study letter” is generated for each new study to be carried out under the framework agreement. The addendum specifies items specific to a particular study, such as the dollar amount, the name of the protocol, and the lead auditor. These additions are „attached” to each framework agreement.
This reduces the need to „reinvent” oneself in an agreement for each study with that sponsor; the main terms are agreed and only the details need to be negotiated. .
