SOP-307
Case Report Forms, EDC Entry and Query Resolution
- Number
- SOP-307
- Category
- Study Conduct
- Edition
- Reference Edition 1.3
- Approx. pages
- 4
[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] enters trial data into case report forms (CRFs), most often in the sponsor's electronic data capture (EDC) system, responds to data queries, and gives investigator sign-off, so that reported data match source and are submitted on time.
2. Scope
This SOP applies to all paper and electronic CRFs and other sponsor data acquisition tools completed by site staff, and to all staff with EDC access.
Out of scope: creating and correcting source records (SOP-306); access management for site-owned systems (SOP-401); ePRO data entered by participants (SOP-306 section 5.6).
Where the protocol, CRF completion guidelines, sponsor or IRB sets a stricter requirement than this SOP, the stricter requirement applies.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Responsible for the accuracy, completeness, legibility and timeliness of data reported to the sponsor. Reviews and signs eCRFs or casebooks at the milestones the sponsor sets. Answers or approves queries on medical judgment. |
| Sub-Investigator (Sub-I) | Answers queries on assessments they made. Signs eCRFs where the sponsor allows Sub-I signature. |
| Clinical Research Coordinator (CRC) | Enters data from source within the required time, answers queries with source support, and tracks open queries. |
| Lead CRC | Monitors entry and query timeliness for the study and reports backlogs to the PI and Site Director. |
| Regulatory Coordinator | Requests EDC accounts for delegated staff and removal of access when staff leave. Files EDC training certificates. |
| Quality Lead | Reviews EDC timeliness and query metrics during internal QC (SOP-700). |
4. Definitions
| Term | Definition |
|---|---|
| Case Report Form (CRF) | A data acquisition tool designed to record protocol-required information to be reported by the investigator to the sponsor on each participant. An electronic CRF is an eCRF. |
| Electronic Data Capture (EDC) | The sponsor's computerized system used to collect CRF data from sites. |
| Data Query | A question raised by the sponsor, monitor, data manager or an automated edit check about a data point that appears missing, inconsistent or out of range. |
| Data Clarification Form (DCF) | A paper or electronic form used to raise and answer a query outside the EDC query function, usually for paper CRFs. |
| Investigator Signature | The PI's or delegated investigator's electronic or handwritten signature attesting that they reviewed the CRF data and that the data are accurate and complete to the best of their knowledge. |
| Data Lock | A sponsor action that prevents further changes to some or all data, for example at an interim analysis or database lock. |
| Source Data Verification (SDV) | Comparison by the monitor of CRF data against source records. |
5. Procedure
5.1 EDC Access and Training
5.1.1
Staff receive EDC access only after the PI has delegated data entry on F-302-01 and the staff member has completed the sponsor's EDC training. The Regulatory Coordinator files the training certificate and records the account on F-401-01.
5.1.2
Each user keeps their own credentials private. Staff never enter data under another person's login. An electronic signature in EDC is treated as the legally binding equivalent of the user's handwritten signature (21 CFR 11.100).
5.1.3
When a staff member leaves or no longer needs access, the Regulatory Coordinator asks the sponsor to deactivate the account [DEFAULT: the same business day the change takes effect] and records the request on F-401-01.
5.1.4
Staff read the CRF completion guidelines for the study and keep the current version available.
5.2 Data Entry
5.2.1
The CRC enters data from the source records listed on the Source Data Location List (SOP-306). Data are not entered from memory or from unofficial notes.
5.2.2
Where the sponsor has approved direct entry into EDC as source for certain data items, staff enter those data at the time of the activity, and the EDC record is source for them.
5.2.3
The CRC enters visit data [DEFAULT: within 5 business days of the visit, unless the sponsor specifies a different time]. Data needed for safety or eligibility (for example SAE forms, eligibility pages, randomization data) are entered within any shorter time the sponsor requires.
5.2.4
When source data are not yet available (for example a pending lab result), the CRC enters what is available and completes the form when the data arrive. Fields are not left blank without the reason the CRF guidelines require (not done, not applicable, unknown).
5.2.5
The CRC checks each page against source before saving and resolves edit-check messages that indicate entry errors.
5.2.6
Free-text fields hold only the information requested. Staff do not enter participant names, initials (unless the CRF requires them), medical record numbers or other direct identifiers.
5.2.7
Investigator judgments (eligibility, AE causality and seriousness, clinical significance of results) are entered only as documented by the investigator in source.
5.3 Paper CRFs
5.3.1
Paper CRFs are completed in blue or black ink, legibly, with all required fields completed or marked as the guidelines direct.
5.3.2
Corrections follow the single-line method in SOP-306 section 5.5: single line through the error, correct value, initials, date and reason where not obvious.
5.3.3
Staff send CRF copies as the sponsor directs, keep the site copy, and record the transmission date.
5.4 Query Resolution
5.4.1
The CRC reviews open queries in EDC at least [DEFAULT: weekly] and before each monitoring visit.
5.4.2
The CRC answers each query [DEFAULT: within 5 business days of the query being raised, unless the sponsor specifies a different time].
5.4.3
Every answer is supported by source. The CRC checks source before replying and states the source in the response where helpful (for example "Per clinic note dated [DATE], value confirmed").
5.4.4
If source shows the EDC value was wrong, the CRC corrects the EDC entry so it matches source and gives the reason. If the EDC value matches source, the CRC confirms the value and does not change it.
5.4.5
If the source itself is wrong or incomplete, the CRC first corrects the source under SOP-306 (with the investigator for clinical assessments), then corrects EDC.
5.4.6
Queries that need medical judgment are sent to the investigator who made the assessment, or another delegated investigator, who answers or approves the response.
5.4.7
Staff never change data only to close a query or to satisfy an edit check. If the query asks for a value the source does not support, the CRC answers that the data are not available or as recorded, and explains.
5.4.8
For paper DCFs, the responder completes the DCF, signs and dates it, has the investigator sign where required, returns it to the sponsor, and files the site copy with the CRF.
5.5 Investigator Review and Signature
5.5.1
The PI, or a delegated investigator where the sponsor allows, reviews the participant's CRF data and signs electronically at the milestones the sponsor sets (for example after each visit, at interim analysis, at end of study or before database lock).
5.5.2
Before signing, the investigator reviews the data, with particular attention to eligibility, adverse events, concomitant medications, IP exposure and study endpoints, and raises any concern with the CRC.
5.5.3
If data are changed after signature, EDC usually removes the signature. The investigator re-signs once the change is reviewed.
5.5.4
The PI does not sign before data are complete and queries on critical fields are resolved, unless the sponsor requests signature for a defined milestone and the open items are known.
5.6 Data Locks and Post-Lock Changes
5.6.1
The Lead CRC tracks sponsor timelines for interim and final locks and plans data entry, query resolution and investigator signature to meet them.
5.6.2
After a lock, staff make no changes in EDC. If an error is found after lock, the CRC informs the sponsor, follows the sponsor's unlock or correction process, and records the issue in the participant file.
5.7 Data Copies at Study End
5.7.1
At study end, the Regulatory Coordinator obtains from the sponsor the site's copy of its eCRF data, including audit trail, in a readable format, checks that it opens and covers all participants, and files it for the retention period (SOP-402, SOP-601).
5.8 Metrics and Follow-Up
5.8.1
The Lead CRC reviews data entry backlog and open query age monthly and reports items past the default timelines to the PI and Site Director.
5.8.2
Repeated late entry or high query rates for a study or staff member are addressed by retraining, workload changes or CAPA (SOP-703).
6. Related Forms and SOPs
- F-302-01 Delegation of Authority Log
- F-401-01 Computerized System Inventory and Access Log
- F-103-01 Staff Training Log
- F-905-01 Cross-Entity Data Flow Register (Model N only)
- SOP-302 Delegation of Authority
- SOP-306 Source Documentation and Data Integrity (ALCOA+)
- SOP-401 Computerized Systems and Electronic Records
- SOP-402 Record Retention, Archiving and Destruction
- SOP-501 Serious Adverse Event and Expedited Safety Reporting
- SOP-600 Sponsor Monitoring Visits
- SOP-601 Study Closeout
- SOP-700 Internal Quality Control and Quality Assurance Audits
- SOP-703 Corrective and Preventive Action (CAPA)
- SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
- SOP-905 Network Data, Systems, Privacy and Records Across Sites (Model N only)
- Appendix B Central and Site Responsibility Matrix (Model N only)
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 | Data Life Cycle Elements |
| FDA Guidance (Sept 2013) | Electronic Source Data in Clinical Investigations |
| FDA Guidance (Oct 2024) | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
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.