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 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.

Examples of Source Documents in a sentence

  • Health Services Provider shall maintain all Study Documentation, including Source Documents (each as defined below) and any other records required to be maintained under Applicable Laws, in a manner acceptable for the collection of data for submission to, or review by, applicable regulatory or governmental authorities and in accordance with Applicable Laws.


More Definitions of Source Documents

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 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 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 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.
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 means documents containing Data that are or may be required as part of a Data Transmission concerning a claim for payment of charges for medical services that a Provider furnishes or medical supplies that a Supplier sells to a Covered Individual. Source Documents are subject to the security standards of Article V of this Agreement. Examples of Data contained within a Source Document include, without limitation, Individual’s name and identification number, claim number, diagnosis codes for the services rendered, dates of service, service procedure descriptions, applicable charges for the services rendered, the Provider’s or Supplier’s name, National Provider Identifier, and signature.