INVESTIGATOR SOURCE DATA AGREEMENT (SDA)
Study Title:
Principal Investigator:
IRB Number:
Site:
This Source Data Agreement (SDA) applies to the information recorded in a subject’s source documents and should comprise, at minimum, all the data as required per protocol. It is important to make clear to all study team members, study monitors and potential auditors where source documentation – the original recording – will be collected and stored for each item of data you collect for the study.
ICH GCP 1.51 defines Source Data as “All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial”.
To begin, please review your protocol for your key data points and work out where you will first record/ obtain this data.
- There should only be one source defined at any time for any data item.
- With regards to electronic source data, the earliest record that it is practical to retain should be considered as the location of the source data and therefore the source document.
- With regards to using an electronic medical record (EMR) for source data, it is preferable to list the actual location within the EMR for each parameter. This will increase efficiency of monitors by reducing monitoring time and decreasing data queries.
| Study Data Category | Source Location (see list below, enter number(s) as appropriate) | PI Initials |
| Eligibility Criteria | ||
| Informed Consent Process Note | ||
| Randomization | ||
| Demographics | ||
| Medical History | ||
| Physical Examinations | ||
| Study Visit Information/Procedures | ||
| Vitals (height/weight/BP) | ||
| Questionnaires/Diaries | ||
| Pathology Tests/Results | ||
| Laboratory Test/Results | ||
| ECG | ||
| Study Drug/Device Accountability | ||
| Study Drug/Device Compliance | ||
| Adverse Events | ||
| Concomitant Medications | ||
| Deviations | ||
| Outside Records | ||
| <Insert other study-specific item> | ||
| <Insert other study-specific item> |
- Direct entry to EMR
- Direct entry to Electronic Data Capture system (EDC)
- Stored on device/ automated instrument
- Paper form
- Other
I confirm that this is the complete record of source documentation and the monitors and auditors (as applicable) will be provided with all available source data when requested.
Principal Investigator Signature:
Date: