SOP-600
Sponsor Monitoring Visits
- Number
- SOP-600
- Category
- Monitoring and Closeout
- Edition
- Reference Edition 1.3
- Approx. pages
- 5
[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] prepares for, hosts and follows up on sponsor monitoring, whether performed on site, remotely or centrally, and how monitoring findings are tracked to closure.
2. Scope
This SOP applies to all monitoring activity by sponsors, CROs and their designees for trials at [SITE NAME], including site qualification and initiation visits where the same logistics apply. It covers on-site visits, remote monitoring (remote source data verification and review), and responses to centralized monitoring findings.
Out of scope: close-out visit content (SOP-601), sponsor and IRB audits (SOP-701), and regulatory inspections (SOP-702).
Follow the protocol, CTA, monitoring plan or IRB requirement where it is stricter than or more specific than this SOP.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Permits monitoring (ICH E6(R3) Annex 1, 2.3.5), meets the monitor as the sponsor requests, reviews significant findings, and approves the response to findings that involve investigator judgment, safety or compliance. |
| Lead CRC or CRC | Schedules visits, prepares records, hosts the monitor, answers questions and queries, tracks action items on F-600-02, and keeps F-600-01 current. |
| Regulatory Coordinator | Prepares the ISF for review, resolves regulatory findings, and files visit confirmation and follow-up letters. |
| Research Pharmacist or IP Manager | Makes IP storage, accountability and temperature records available, and resolves IP findings. |
| Site Director | Provides workspace and system access, and resolves escalated or resource-related findings. |
| Quality Lead | Approves and audits monitor access to the EHR and other systems, reviews F-600-02 for overdue and repeated findings, and opens CAPA where needed (SOP-703). |
4. Definitions
| Term | Definition |
|---|---|
| Monitoring | Activities by the sponsor or its designee to oversee the progress of a trial and confirm that participants' rights, safety and well-being are protected, data are reliable, and the trial is conducted per the protocol, GCP and regulations. |
| On-site monitoring | Monitoring performed by the monitor at the site. |
| Remote monitoring | Monitoring performed away from the site, through remote, secure, read-only access to source records, eSource, the ISF or certified copies (ICH E6(R3) Annex 1, 3.11.4.1(c)). |
| Centralized monitoring | Evaluation of accumulated data by the sponsor (for example, statistical and data trend review) to identify risks, data anomalies or site performance issues (ICH E6(R3) Annex 1, 3.11.4.2). |
| Risk-based monitoring | A monitoring approach in which the type, frequency and intensity of monitoring are set according to the identified risks to critical to quality factors. |
| Source data verification (SDV) | Comparison of data entered in the CRF with the source records. |
| Source data review (SDR) | Review of source records for protocol compliance, quality and completeness, independent of CRF entries. |
| Certified copy | A copy of the original record, verified by a dated signature or by a validated process, to have the same information as the original, including relevant metadata (ICH E6(R3) Glossary). |
| Follow-up letter | The sponsor's written summary to the site of the visit, findings and actions required. |
| Direct access | Permission to examine, analyze, verify and reproduce records and reports important to evaluation of a trial, with appropriate precautions for confidentiality. |
5. Procedure
5.1 Setup at study start
5.1.1
At the site initiation visit, the Lead CRC obtains and files the monitoring plan summary or monitoring expectations the sponsor shares: visit frequency, SDV/SDR approach, remote monitoring method, and centralized monitoring triggers.
5.1.2
The Lead CRC confirms with the sponsor how remote monitoring will be done for this study: direct read-only access to the EHR or eSource, certified copies uploaded to a sponsor portal, or a combination. The method must be permitted by the CTA and covered by the participant's consent and HIPAA authorization (SOP-400).
5.1.3
The Quality Lead approves each monitor account for site systems before it is used (SOP-401):
- one named account per monitor; shared accounts are not used
- read-only access, restricted where the system allows to records of consented participants in the monitor's studies
- access logged on F-401-01 with start date, and removed when the monitor no longer needs it, or at study close
- the monitor's signed confidentiality or EHR access agreement on file
- audit trail of access available for review
5.1.4
Where the EHR cannot restrict a monitor to study participants, the Quality Lead documents the risk assessment and either uses supervised access (a staff member drives the screen) or certified copies.
5.2 Scheduling
5.2.1
The Lead CRC agrees visit dates with the monitor and records each visit on F-600-01 when confirmed. The Lead CRC asks for the sponsor's confirmation letter or agenda, listing participants and records to be reviewed.
5.2.2
The Lead CRC books workspace (for on-site visits), confirms PI or Sub-I availability for a meeting during the visit, and confirms availability of the Regulatory Coordinator and the Research Pharmacist or IP Manager.
5.2.3
For remote visits, the Lead CRC confirms the method and access window, and checks that the monitor's access works before the visit date.
5.3 Preparation
5.3.1
Before each visit, by [DEFAULT: 1 business day before the visit], the Lead CRC confirms that:
- data for completed visits are entered in EDC within the SOP-307 timeline
- open queries are answered or have a documented status
- participant research records for the participants listed are complete, filed and signed
- SAEs and pregnancies have been reported and follow-ups are current (SOP-501, SOP-503)
- deviations are logged on F-308-01
- action items from the previous follow-up letter are complete or have a status on F-600-02
5.3.2
The Regulatory Coordinator updates the ISF, including delegation log, training records, IRB correspondence, consent versions and safety report acknowledgments.
5.3.3
The Research Pharmacist or IP Manager updates accountability (F-304-01) and temperature logs (F-304-02), and prepares IP for review.
5.3.4
For remote review by certified copy, the CRC prepares certified copies under SOP-306 and uploads them only to the sponsor-approved secure system. Copies are redacted and checked under the single redaction rule in SOP-400 5.4.1. Copies are not sent by ordinary email.
5.4 Conduct of the visit
5.4.1
At an on-site visit, the monitor signs F-600-01 (and the sponsor's site visit log where one is used). The CRC gives the monitor the agreed workspace and records.
5.4.2
Source records and the ISF are not removed from the site. The monitor does not write in source records, the ISF or participant charts, and does not sign site records except the visit log.
5.4.3
The CRC answers questions during the visit and records corrections made in response, following good documentation practice (SOP-306). Corrections are made by the person who made the original entry or a delegated staff member, never by the monitor.
5.4.4
The PI or Sub-I meets the monitor when requested to discuss enrollment, safety, deviations and significant findings. If the PI cannot attend, the PI schedules a call within [DEFAULT: 5 business days] and the CRC records it.
5.4.5
At the exit meeting, the Lead CRC records the findings and action items discussed on F-600-02 without waiting for the follow-up letter.
5.4.6
For remote visits, staff do not share screens showing records of participants outside the study, and close remote sessions at the end of the agreed window.
5.5 Centralized monitoring findings
5.5.1
The CRC responds to centralized monitoring communications (data trend queries, key risk indicator alerts, out-of-range patterns) within the sponsor's timeline, or [DEFAULT: 5 business days] where none is stated.
5.5.2
Findings that suggest a systemic site issue (for example, unusual data patterns, high screen failure rates, late data entry) are brought to the PI and Quality Lead and recorded on F-600-02.
5.6 Follow-up letters and action tracking
5.6.1
The Lead CRC reviews each follow-up letter within [DEFAULT: 5 business days of receipt] and checks it against the exit meeting notes. Errors in the letter are reported to the monitor in writing.
5.6.2
Each action item is entered on F-600-02 with owner, due date and status. Due dates follow the sponsor's timeline; where none is given, items are due by [DEFAULT: 30 calendar days or before the next visit, whichever comes first].
5.6.3
Findings involving participant safety, consent, eligibility or IP are brought to the PI the day they are identified and are not left for the follow-up letter.
5.6.4
The PI reviews F-600-02 for each study at least [DEFAULT: monthly] and initials the review.
5.6.5
Findings that are protocol deviations are recorded on F-308-01 (SOP-308). Findings that meet IRB reporting criteria are reported under SOP-502.
5.6.6
Follow-up letters, confirmation letters and the site's correspondence are filed in the ISF (SOP-204). Sponsor monitoring reports are sponsor records and are not usually given to the site.
5.7 Escalation of unresolved findings
5.7.1
An action item that is overdue, or is repeated in a second follow-up letter, is escalated by the Lead CRC to the PI and Quality Lead.
5.7.2
The Quality Lead decides whether a CAPA is needed (SOP-703) and records the decision on F-600-02.
5.7.3
Disagreements with a monitor's finding are discussed with the monitor and, if unresolved, raised in writing by the PI with the sponsor's study manager. The site's position and the outcome are filed in the ISF.
5.7.4
The Site Director resolves findings that need resources or a change in staffing or workload.
5.7.5
Monitor conduct concerns (for example, requests to change data without a source basis, or access beyond agreed scope) are reported to the Quality Lead and, if needed, to the sponsor. Requests to falsify records are handled under SOP-704.
5.8 Quality review
5.8.1
As part of the quarterly metrics review in SOP-700 5.7.1, the Quality Lead reviews F-600-02 across studies for overdue actions and repeated findings across studies, and reviews monitor access logs on F-401-01 against active monitor assignments.
6. Related Forms and SOPs
- F-600-01 Monitoring Visit Log
- F-600-02 Monitoring Follow-Up Action Tracker
- F-304-01 Investigational Product Accountability Log
- F-304-02 Temperature Monitoring Log
- F-308-01 Protocol Deviation Log
- F-401-01 Computerized System Inventory and Access Log
- SOP-204 Essential Documents and the Investigator Site File
- SOP-306 Source Documentation and Data Integrity (ALCOA+)
- SOP-307 Case Report Forms, EDC Entry and Query Resolution
- SOP-308 Protocol Deviations and Noncompliance
- SOP-400 Participant Privacy and HIPAA in Research
- SOP-401 Computerized Systems and Electronic Records
- SOP-502 Unanticipated Problems and Reportable New Information
- SOP-601 Study Closeout
- SOP-701 Sponsor and IRB Audits
- SOP-703 Corrective and Preventive Action (CAPA)
- SOP-704 Research Misconduct and Fraud Reporting
- SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation) (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 312.56(a) | Review of Ongoing Investigations (sponsor monitoring) |
| 21 CFR 812.46 | Monitoring Investigations |
| 21 CFR 11 | Electronic Records; Electronic Signatures |
| 45 CFR 164.508 | Uses and Disclosures for Which an Authorization Is Required |
| ICH E6(R3) Annex 1, 2.3.5 | Investigator: Permitting Monitoring, Audit and Inspection |
| ICH E6(R3) Annex 1, 2.12.14 | Records: Direct Access |
| ICH E6(R3) Annex 1, 3.11.4 | Monitoring |
| FDA Guidance (2013) | Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring |
| FDA Guidance (Oct 2024) | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
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