Examples of Data Lock in a sentence
The Authority will accept a single harmonized IBD and Data Lock Point (DLP) for each product in order to reduce the burden of work in preparing PSURs/PBRERs for different regulatory authorities.In situations where an MAH is preparing PSURs/PBRERs on annual basis or longer period for different regulatory authorities based on the IBD and the Authority requires a six-month cycle based on the LBD, the most recent PSUR/PBRER with a longer time frame will be acceptable to the Authority.
An authorization pursuant to this subsection shall not authorize the construction of permanent structures or facilities on the public lands.
Remote SDV should at this point only be required for a few clinical trials: • Clinical trials investigating treatment and prevention of COVID-19• Pivotal clinical trials soon reaching Data Lock Point and thereby trial com- pletion, analysis and reporting of trial data.Implementation of remote access must be carried out in close collaboration with the site investigators.
In the event of a Shelf Registration, the Company shall bear or reimburse the Holders of the Securities covered thereby for an amount not to exceed $25,000 for the reasonable fees and disbursements of one firm of counsel designated by the Holders of a majority in principal amount of the Initial Securities and the Accredited Investor Securities covered thereby to act as counsel for the Holders of the Initial Securities and the Accredited Investor Securities in connection therewith.
The Report concluded:The carer research literature contains multiple recommendations for well-designed randomised controlled trials and, in our view there is no doubt that these are required to strengthen the evidence base for carer interventions.