Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Electronic Source Data in Clinical Investigations Sep-2013 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Electronic Source Data in Clinical Investigations |
| Version / Revision | Sep-2013 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance for Industry Electronic Source Data in Clinical Investigations |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.2.2 |
| Scope | G |
| Document part | III 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Electronic records, Source documents, Case report form, Electronic data capture, FDA |
Content
III. Electronic Source Data [...] 2. Source Data Capture Data can be entered into the eCRF either manually or electronically as described below. a. Direct Entry of Data Into the eCRF Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. This direct entry of data can eliminate errors by not using a paper transcription step before entry into the eCRF. For these data elements, the eCRF is the source. If a paper transcription step is used, then the paper documentation should be retained and made available for FDA inspection (see section III.A.2.c). When pertinent supportive information is available, FDA could request other documents during an inspection to corroborate a direct entry of source data elements into the eCRF by an authorized data originator. For example, at an initial visit, a clinical investigator might ask a subject about underlying illnesses, and proceed to enter the illness(es) in an eCRF. During an FDA inspection, a record may be requested for evidence of testing or the use of medications to corroborate a diagnosis.
