SOP-07
Source Documentation and EDC
- Number
- SOP-07
- Category
- Core
- Edition
- Lean Edition 2.0
- Approx. pages
- 6
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [SITE NAME] defines, records, corrects and protects source records, enters data into case report forms (CRFs), most often in the sponsor's electronic data capture (EDC) system, and resolves queries, so that every reported value can be traced to source and to the person who recorded it.
2. Scope
This SOP applies to all source records for every study at [SITE NAME], paper or electronic, including the electronic health record (EHR), study worksheets, participant diaries and ePRO, device outputs and outside records, and to all paper and electronic CRFs and staff with EDC access. Validation and access control of site-owned systems and record retention are in SOP-12. Suspected falsification is reported under SOP-M5 (if adopted) or, if not adopted, to the PI and Quality Lead.
Where the protocol, CRF completion guidelines, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Responsible for the integrity of data under the site's control and for the accuracy and timeliness of data reported to the sponsor. Approves the Source Data Location List. Reviews source data and signs eCRFs at sponsor milestones. Answers or approves queries on medical judgment. |
| Sub-Investigator (Sub-I) | Records and signs clinical assessments in source. Answers queries on assessments they made. Signs eCRFs where the sponsor allows. |
| Clinical Research Coordinator (CRC) | Records data at the time of the activity, files outside records, makes certified copies, enters EDC data from source and answers queries with source support. |
| Lead CRC | Drafts and maintains the Source Data Location List and source worksheets. Tracks entry, query and lock timelines for the study. |
| Regulatory Coordinator | Files the Source Data Location List and source templates in the ISF. Requests and removes EDC accounts and records them on F-401-01. Obtains the site's eCRF data copy at study end. |
| Quality Lead | Checks source and EDC quality in QC (SOP-14). Reviews Notes to File for misuse. |
| All Research Staff | Record only what they did or observed, under their own identity. |
4. Definitions
| Term | Definition |
|---|---|
| Source records | Original documents or data (including relevant metadata), or certified copies, in any media, in which trial data are first recorded. |
| ALCOA+ | Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available. |
| Audit trail | A secure, computer-generated, time-stamped record of each entry and change, by whom, when and, where applicable, why. |
| Certified copy | A copy verified by dated signature, or generated by a validated process, to have the same information as the original, including relevant metadata. |
| Source Data Location List | A study-specific document, approved by the PI before the first participant visit, stating where each data item is first recorded. |
| Late entry | An entry made more than [DEFAULT: 1 business day] after the event, labeled as late. |
| Note to File (NTF) | A signed and dated explanation on F-306-01 of a recordkeeping issue or decision not evident from other records (SOP-03). |
| Case report form (CRF) | A paper or electronic tool for recording the protocol-required data reported to the sponsor on each participant. |
| Data query | A question from the sponsor, monitor, data manager or an edit check about a data point that appears missing, inconsistent or out of range. |
5. Procedure
5.1 ALCOA+ rules for every entry
5.1.1
All Research Staff record study data so that each entry is:
- attributable: signed or initialed by an identifiable person (study staff are on F-302-01), or made under their own login
- legible and permanent: paper entries in blue or black ink
- contemporaneous: recorded at the time of the activity; anything later than [DEFAULT: 1 business day] is a late entry (5.5.4)
- original: recorded first where the Source Data Location List says, never on scrap paper, sticky notes or personal devices
- accurate and complete: values, units and times as measured; blank fields marked "not done", "not applicable" or "unknown" with initials and date
- consistent across records, or the difference explained
- enduring and available for the full retention period
5.1.2
Staff do not use pencil, correction fluid or tape, erasable pens or labels over entries. Staff never backdate, sign for another person or share a login.
5.1.3
Staff never create, alter or remove data to make a record look complete or compliant.
5.2 Defining source for each study
5.2.1
Before the first participant visit, the Lead CRC prepares a Source Data Location List stating where each protocol data category is first recorded, for example consent (consent form and F-301-01), medical history and medications, vital signs and exams, eligibility (F-303-02), adverse events and investigator assessments, IP (F-304-01, F-304-04, IRT), laboratory reports, and data captured directly in EDC, ePRO, IRT or devices.
5.2.2
The PI signs the list, and the Regulatory Coordinator files it in the ISF. Where the sponsor allows direct entry into EDC or ePRO, the list names that system as source, and staff do not keep a second paper source.
5.2.3
The Lead CRC updates the list when an amendment, new system or process change alters where data are first recorded, and the PI signs each version.
5.2.4
Study worksheets show their version and the protocol version they support, and are reviewed against each amendment. Sponsor worksheets are checked so they do not prompt staff to record data the protocol does not require.
5.3 EHR, outside records and certified copies
5.3.1
Where the EHR is source, staff record data in the EHR at the visit and identify it as a research visit where the system allows. Research-only data the EHR cannot hold go on listed worksheets. Clinical information that affects routine care (new diagnoses, abnormal results, new medications) is also recorded in the medical record.
5.3.2
The Site Director confirms the EHR keeps an audit trail; monitor access follows the SOP-13 Site decision.
5.3.3
Outside records (discharge summaries, specialist notes, outside labs) are original source when received and are filed in the participant's research record, as originals or certified copies.
5.3.4
To certify a paper copy, the staff member compares it with the original, confirms it is complete and legible, and signs and dates it as a true and complete copy. A certified copy of an electronic record keeps the relevant metadata or comes from a validated process. An original is destroyed only if a certified copy replaces it and the sponsor and SOP-12 allow it.
5.3.5
The research file must not become a second, conflicting medical record. Where a data item appears in more than one place, the list says which is source, and conflicts are resolved by correcting the error under 5.5, not by choosing a value in EDC.
5.4 Participant-reported data and devices
5.4.1
Paper diaries are source. Staff review them with the participant at the visit and record any clarification separately, dated and initialed, never altering the participant's entry.
5.4.2
ePRO data are source in the sponsor's system. Staff train the participant, record the training in source, and enter data on the participant's behalf only where the protocol allows and the entry is attributed correctly.
5.4.3
Where the site issues devices or wearables, staff record the serial number against the participant (ICH E6(R3) Annex 1, 2.12.10(d)).
5.4.4
Problems with ePRO, wearables or other sponsor systems that may affect data are reported to the sponsor's help desk and recorded. Incidents with possible significant or persistent impact on data or security are also reported to the sponsor and, where applicable, the IRB (SOP-12).
5.4.5
For each study using ePRO or devices, the PI names on the study's PI oversight note who reviews device compliance reports and alerts, how often (the protocol's frequency, or [DEFAULT: at least weekly]) and who covers alerts outside business hours; reviews are dated in source. Staff train participants on charging, syncing and what to do when a device fails, and record the training. Staff do not install apps on, or access personal data on, a participant's own device except as the protocol and consent describe.
5.5 Correcting source and late entries
5.5.1
Paper corrections: a single line through the error so the original stays readable, the correct value, initials, date, and a short reason where not obvious (for example "transcription error").
5.5.2
Electronic corrections use the system's correction function so the audit trail keeps the original value, new value, who, when and why. Staff do not delete and re-create records.
5.5.3
Corrections are supported by source and made within [DEFAULT: 5 business days] of the error being found, or the sponsor's query time if shorter. Only the person who made the entry, or a delegated person who knows the correct information, corrects it. A clinical assessment (for example AE causality or eligibility) is corrected only by the investigator who made it or another delegated investigator. Monitors and sponsor staff never write in site source.
5.5.4
A late entry is labeled "Late entry", dated with the date written, refers to the event date, states the reason for the delay and the information source (for example "from participant phone call on [DATE]"), and is signed.
5.5.5
Staff do not rewrite a page to make it neater. A damaged record that must be recreated is kept with the new one, with the reason recorded.
5.6 Investigator review of data
5.6.1
Investigators review study data, including outside data that can affect eligibility, treatment or safety (central lab results, central reads, outside records, ePRO alerts), within the protocol's time or, where the protocol is silent, the result review times in SOP-02.
5.6.2
The investigator shows the review by signing and dating the report or record, signing a visit note, or electronic sign-off, and records the assessment and any action for clinically significant findings.
5.7 Notes to File
5.7.1
Notes to File follow SOP-03 and use F-306-01. In source, an NTF may explain where a record is kept or how data were captured during a system outage. It never replaces missing source data: a missing assessment stays missing and is handled under SOP-08. Repeated NTFs on one issue are referred for CAPA (SOP-08).
5.8 EDC access and data entry
5.8.1
Staff receive EDC access only after the PI delegates data entry on F-302-01 and the person completes the sponsor's EDC training. The Regulatory Coordinator files the certificate and records the account on F-401-01, and asks the sponsor to deactivate it [DEFAULT: the same business day] the person leaves or no longer needs it.
5.8.2
Each user keeps their credentials private and never enters data under another login. An EDC electronic signature is the legally binding equivalent of a handwritten signature (21 CFR 11.100). Staff keep the current CRF completion guidelines available.
5.8.3
The CRC enters data only from source on the Source Data Location List, never from memory or unofficial notes, and checks each page against source before saving.
5.8.4
The CRC enters visit data [DEFAULT: within 5 business days of the visit], or the sponsor's time if different. SAE, eligibility and randomization data are entered within any shorter time the sponsor sets.
5.8.5
Pending data are entered when they arrive. Fields are not left blank without the reason the guidelines require.
5.8.6
Free-text fields hold only what is asked. Staff do not enter names, medical record numbers or other direct identifiers, or initials unless the CRF requires them.
5.8.7
Investigator judgments (eligibility, AE seriousness and causality, clinical significance) are entered only as the investigator documented them in source.
5.8.8
Paper CRFs follow 5.1 and 5.5. Staff send copies as the sponsor directs, keep the site copy and record the date sent.
5.9 Queries
5.9.1
The CRC answers each query [DEFAULT: within 5 business days of it being raised], or the sponsor's time if different, and reviews open queries before each monitoring visit.
5.9.2
Every answer is checked against source. If source shows the EDC value was wrong, the CRC corrects EDC with a reason. If EDC matches source, the CRC confirms the value. If the source is wrong, the CRC corrects source first under 5.5, then EDC.
5.9.3
Queries needing medical judgment go to the investigator who made the assessment, or another delegated investigator, who answers or approves the response.
5.9.4
Staff never change data only to close a query or satisfy an edit check. Where source does not support the requested value, the CRC answers that the data are as recorded or not available.
5.9.5
Paper data clarification forms are signed and dated by the responder (and the investigator where required), returned to the sponsor, and filed with the CRF.
5.10 Investigator signature, locks and study end
5.10.1
The PI, or a delegated investigator where the sponsor allows, reviews the CRF data, with attention to eligibility, adverse events, concomitant medications, IP exposure and endpoints, and signs at the milestones the sponsor sets. The PI does not sign before data are complete and critical queries are resolved, unless the sponsor asks for signature at a defined milestone and the open items are known. Data changed after signature are reviewed and re-signed.
5.10.2
The Lead CRC tracks sponsor lock dates and plans entry, queries and signatures to meet them. After a lock, staff make no EDC changes; an error found after lock is reported to the sponsor, handled by the sponsor's unlock or correction process and noted in the participant file.
5.10.3
At study end, the Regulatory Coordinator obtains from the sponsor the site's copy of its eCRF data with audit trail in a readable format, checks that it opens and covers all participants, and files it for retention (SOP-12, SOP-15).
5.10.4
Repeated late entry or high query rates for a study or person, found by the monitor, QC or the Lead CRC, are addressed by retraining, workload change or CAPA (SOP-08).
5.11 Protecting source
5.11.1
Source is stored with access limited to authorized staff (locked cabinets, restricted folders, role-based system access). Paper source leaves the site only under SOP-12 or SOP-M4 (if adopted).
5.11.2
Data sent to the sponsor carry the participant code only; the code list stays at the site (SOP-05).
5.11.3
Site-owned systems holding source have an audit trail that cannot be switched off, unique user accounts and backup (SOP-12). Audit trails are never altered.
5.11.4
Staff do not send source by personal email, text message, unencrypted removable media or personal cloud storage. Data moved between systems are checked for completeness with metadata (SOP-12). Privacy incidents follow SOP-12.
6. Related Forms and SOPs
- F-306-01 Note to File
- F-301-01 Informed Consent Process Note
- F-302-01 Delegation of Authority Log
- F-303-02 Eligibility Verification Checklist
- F-304-01 Investigational Product Accountability Log
- F-304-04 Participant IP Dispensing and Return Log
- F-401-01 Computerized System Inventory and Access Log
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-03 IRB Oversight, Essential Records and Study Activation
- SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding
- SOP-08 Protocol Deviations and CAPA
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-13 Monitoring, Audits and Inspections
- SOP-14 Quality Control and Quality Review
- SOP-15 Study Closeout
- SOP-M4 Decentralized Trial Elements (if adopted)
- SOP-M5 Research Integrity and Misconduct Reporting (if adopted)
7. References
| Reference | Title |
|---|---|
| 21 CFR 11 | Electronic Records; Electronic Signatures |
| 21 CFR 312.62(b) | Investigator recordkeeping: case histories |
| 21 CFR 812.140(a)(3) | Records: participant case records |
| ICH E6(R3) Annex 1, 2.12 | Records |
| ICH E6(R3) Annex 1, 4.2 and 4.3 | Data Life Cycle Elements; Computerised Systems |
| FDA Guidance (Sept 2013) | Electronic Source Data in Clinical Investigations |
| FDA Guidance (2018) | Use of Electronic Health Record Data in Clinical Investigations |
| FDA Guidance (Oct 2024) | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
| Reference Edition SOP-306, SOP-307 | Background and full text |
Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.