Source Documents definition

Source Documents means all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of a Phase 3 Study or any Post-Approval Study in the Development Indication, regardless of form, in each case as maintained by the Institutions.

Source Documents means documentation that supports one or more criterion entered into a person’s record in the CalGang database. Such documents may include, but are not limited to, arrest reports, field interview cards, photographs, and jail records.

Source Documents mean records and data on clinical findings, observations and other activities from clinical practices in subjects of the Research (including analysis data and compiled data thereof), as specified in Annex 7.

Source Documents means original or certified copies (where applicable) of documents presented by an applicant as required under this regulation to the Division of Motor Vehicles to apply for driving privilege card. "State Address Confidentiality Program" means any state-authorized or state-administered program that:

Source Documents means all original documents, including but not limited to, observations and notations of clinical activities relating to the Study and all reports and records necessary for the evaluation and reconstruction of the Study, regardless of form.

Source Documents means documentation of lawfully obtained information that supports one or more criteriaon entered into a person’s record in a shared gang database. Such documents may include, but are not limited to, arrest reports, field interview cards, photographs, and jail records.

Source Documents means documentation of lawfully obtained information that supports one or more criteria entered into a person’s record in the CalGang database. Such documents may include, but are not limited to, arrest reports, field interview cards, photographs, and jail records.

Source Documents means all of BDSI’s data, reports, memoranda and any other development related materials that will be used to support Pre-Approval Regulatory Submissions and Post-Approval Regulatory Submissions.

Source Documents all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study, regardless of form, as maintained by the Investigators, including all laboratory reports, ECG tracings, x-rays, radiologist reports, biopsy reports, ultrasound photographs, Study Subject progress notes, hospital charts, pharmacy records and any other similar reports or records of any procedure performed during the Study. Source Documents include workbooks only when information is recorded directly onto such forms. In the event that the workbook is used as a Source Document by a physician not identified as a primary or secondary investigator in the Protocol or not under the direct supervision of the Investigator, the workbook must be signed and dated by the individual making the entry. Zdrojové dokumenty: všechna zaznamenaná původní pozorování a poznámky o klinických aktivitách a všechny zprávy a záznamy potřebné k vyhodnocení a rekonstrukci Studie, bez ohledu na to, v jaké jsou formě, které vedou a uchovávají Zkoušející, včetně všech laboratorních zpráv, záznamů EKG, rentgenů, zpráv radiologů, zpráv o biopsii, snímků z ultrazvukových vyšetření, poznámek o vývoji stavu Subjektů studie, nemocničních chorobopisů, záznamů lékárny a jakýchkoli jiných podobných zpráv nebo záznamů o jakémkoli úkonu prováděném během Studie. Zdrojové dokumenty zahrnují pracovní záznamy jen v případě, že se informace zaznamenávají přímo na takové formuláře. Pokud pracovní záznam používá jako Zdrojový dokument lékař, který není identifikován jako primární nebo sekundární zkoušející v Protokolu, nebo který nepracuje pod přímým dohledem Zkoušejícího, musí být pracovní záznam podepsán a opatřen datem osobou, která pořizuje záznam.