SOP-16
Business Continuity and PI Coverage
- Number
- SOP-16
- Category
- Core
- Edition
- Lean Edition 2.0
- Approx. pages
- 7
[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] keeps participants safe and protects investigational product (IP), specimens and records when study conduct is disrupted, and how investigator coverage, PI departure and site closure or sale are handled.
2. Scope
This SOP applies to all studies, locations and staff of [SITE NAME]. It covers power loss and storage unit failure, IT outages, severe weather and loss of a location, public health emergencies, absence of key people, PI absence and departure, and closure or sale of a site or location. It is the site's single home for PI absence, coverage and departure; SOP-02 points here.
Life-safety emergencies (fire, medical emergencies in the building, active threat) follow the facility emergency plan at [FACILITY EMERGENCY PLAN LOCATION]. Individual participant medical emergencies follow the protocol and SOP-09.
Where the protocol, sponsor, IRB or clinical trial agreement (CTA) sets a stricter requirement than this SOP, follow it.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Site Director | Owns the plan, declares a continuity event, makes resource decisions, confirms coverage for unplanned PI absence, and leads closure or sale planning. The named backup acts when the Site Director is unavailable (5.6.7). |
| Principal Investigator (PI) | Decides participant safety measures, names covering investigators, writes coverage notes, and notifies sponsors and IRBs of events affecting their studies. |
| Sub-Investigator (Sub-I) | Covers investigator duties when named as covering investigator and listed for the study. |
| Quality Lead | Maintains F-705-01, records events, runs the annual tabletop test, and opens CAPAs under SOP-08. |
| Research Pharmacist or IP Manager | Protects IP during cold-chain events and arranges backup storage under SOP-06. |
| Regulatory Coordinator | Sends sponsor and IRB notifications and handles PI changes and study transfers. |
| Lead CRC / Clinical Research Coordinator (CRC) | Contacts participants, reschedules visits, uses downtime procedures and enters downtime records afterward. |
| [IT SUPPORT PROVIDER] | Restores site-controlled systems and keeps backups. |
| All Research Staff | Know where F-705-01 is kept, keep contact details current, and follow this SOP during an event. |
4. Definitions
| Term | Definition |
|---|---|
| Continuity event | Any event that disrupts or threatens study activities enough to activate this SOP. |
| Critical activities | Safety follow-up and SAE reporting, IP storage and dosing, emergency unblinding, protocol visits within windows, specimen storage and record security. |
| Downtime procedure | A pre-approved manual method used while an electronic system is unavailable, with later entry into the system. |
| Covering investigator | A qualified investigator listed for the study (Form FDA 1572 or device investigator records, and the delegation log) who handles investigator duties during the PI's absence. |
| Investigator-dependent procedures | Consent obtained by an investigator, eligibility confirmation, randomization, IP dosing and AE causality assessment. |
5. Procedure
5.1 The plan (F-705-01)
5.1.1
Before the first study starts at a location, the Site Director and Quality Lead complete F-705-01 Business Continuity Plan and Emergency Contacts for it. The Quality Lead reviews it at the annual test and after any continuity event, staff change, new storage unit, new key system or change of location.
5.1.2
F-705-01 holds:
- the contact tree (staff, PIs and Sub-Is, [IT SUPPORT PROVIDER], building management, alarm service, backup storage, courier, [LEGAL COUNSEL], insurer)
- active studies with sponsor, CRO, monitor, IRB, IxRS and emergency unblinding contacts
- critical activities per location and who does each
- the covering investigator per study and a backup for each key role, including the Site Director (5.6.7)
- backup storage arrangements and sponsor approvals (5.3)
- electronic systems with owner, downtime procedure and recovery target (5.4)
- where downtime forms, coolers, data loggers and conditioned packs are kept
5.1.3
A printed copy sits at [F-705-01 PRINTED COPY LOCATION] at each location, and an electronic copy is reachable off site by the Site Director, Quality Lead and PIs. F-705-01 holds no participant identifiers; it points to the secure system where participant contacts are kept.
5.2 Activation and communication
5.2.1
Any staff member who learns of a continuity event tells the Site Director (or the next person on the contact tree) immediately and protects people first, then IP and specimens, then records.
5.2.2
The Site Director declares the event, activates the contact tree and assigns tasks.
5.2.3
The PI or covering investigator decides participant safety measures for each study: participants with visits due, safety follow-up, IP supply at home and emergency unblinding access.
5.2.4
The Regulatory Coordinator notifies each affected sponsor within [DEFAULT: 1 business day], or sooner if the protocol or CTA requires, and the IRB where its policy requires (SOP-09).
5.2.5
The Quality Lead records the event, actions and effect on studies on F-705-01. Missed or out-of-window visits and other deviations go on F-308-01 (SOP-08).
5.3 Power loss and storage unit failure
5.3.1
Temperature monitoring and alarms for IP and specimen units follow SOP-06. The Site Director records on F-705-01 which units have backup power and for how long.
5.3.2
The site has a written arrangement for backup storage at [BACKUP STORAGE LOCATION] with equivalent temperature control, monitoring and restricted access, under an agreement where the location belongs to another party (SOP-M1, if adopted). IP goes to a backup location only if the sponsor approved that location for the study's IP before use; the Regulatory Coordinator records each study's approval on F-705-01.
5.3.3
When a unit fails or power is lost, the responder keeps the unit closed and checks the reading. If the temperature is expected to leave range before recovery, the IP Manager or, if the IP Manager cannot be reached, any staff member delegated IP tasks on F-302-01 and trained under SOP-06 moves IP and specimens to the backup unit or location in pre-conditioned coolers with a data logger, keeping blinded and study-specific IP separated and labeled.
5.3.4
Where no sponsor-approved backup exists, the IP Manager contacts the sponsor before moving IP, unless waiting would put the IP out of range; then the move is made and reported to the sponsor the same day.
5.3.5
The person who moved the IP records who, when, what and the temperatures before and after on F-304-02. Out-of-range IP is quarantined, documented on F-304-03 and not dispensed until the sponsor confirms in writing it may be used (SOP-06). Specimen excursions are reported under SOP-11.
5.3.6
For power loss affecting other work, the Site Director decides whether visits continue. Procedures that need powered equipment are rescheduled within protocol windows where possible.
5.4 IT and electronic system outages
5.4.1
F-705-01 lists each system used for study conduct (EHR, eSource, EDC, eConsent, eISF, IxRS, ePRO, temperature monitoring, email) with its owner, support contact, downtime procedure and recovery target. Site systems are also on F-401-01 (SOP-12).
5.4.2
Downtime procedures:
- Source and EHR: paper templates at [DOWNTIME FORMS LOCATION]; paper completed in downtime is original source, entered later with the entry date and kept (SOP-07).
- eConsent: the current IRB-approved paper consent if the IRB and sponsor approved its use (SOP-04); otherwise consent is postponed.
- EDC: entry waits for recovery; missed entry timelines are recorded on F-306-01.
- IxRS: the sponsor's backup process; if none, randomization waits. Emergency unblinding uses the sponsor's backup route (SOP-05).
- Safety reporting: the sponsor's backup method (fax, email or phone) within the required time (SOP-09).
- Temperature monitoring: manual readings on F-304-02 as SOP-06 requires until monitoring is restored.
5.4.3
Recovery targets: site-controlled systems are restored by [IT SUPPORT PROVIDER] within the time in the IT support agreement, recorded on F-401-01 and F-705-01; vendor-hosted systems within the time in the vendor's agreement (SOP-12). Backup and restore testing follows the annual restore test in SOP-12. Contingency planning for systems holding protected health information also meets 45 CFR 164.308(a)(7).
5.4.4
A suspected cyberattack or data loss is also handled as a privacy incident under SOP-12.
5.5 Weather, loss of a location and public health emergencies
5.5.1
When severe weather is forecast, the Site Director decides by [DEFAULT: 6:00 pm the previous day] whether to close a location and activates the contact tree.
5.5.2
The CRCs and PI decide for each participant due for a visit: move it within the window, convert it to a remote visit where the protocol permits (SOP-M4, if adopted), or give extra IP only where the protocol and sponsor allow. Staff record contacts on F-309-01 and give participants the emergency contact number.
5.5.3
If a location is damaged or inaccessible, the Site Director decides with the PIs and sponsors whether to move activities. A new location may need sponsor approval, IRB notification or approval and a change to the 1572 information (SOP-02). IP and records move only under documented chain of custody.
5.5.4
In a public health emergency, the Site Director applies public health orders. Changes to study conduct (remote visits, local labs, direct-to-participant IP, alternative consent methods) are made only as the sponsor and IRB approve, except changes to eliminate an apparent immediate hazard, which are made at once and reported under SOP-08. The Site Director pauses new enrollment where staff cannot cover active participants safely.
5.6 PI absence and coverage
5.6.1
The PI gives staff a way to reach the PI or covering investigator whenever participants are on study, including after hours where the protocol requires 24-hour contact. The CRC lists those numbers in IRB-approved participant materials.
5.6.2
For each study, the PI names at least one covering investigator who is listed for the study, trained on the protocol and able to make trial-related medical decisions. The Quality Lead records the name on F-705-01. Where a study has no Sub-I, the PI and Site Director arrange a covering investigator and add that person to the study (1572 or investigator records, F-302-01, and IRB acceptance where its policy requires) before enrollment starts. At feasibility, the Site Director confirms that a covering investigator can be engaged and paid for any study without a Sub-I.
5.6.3
Planned absence over [DEFAULT: 5 business days]. The PI writes a coverage note on F-306-01 naming the covering investigator, dates and contact details and sends it to the study team. The Regulatory Coordinator files it in the ISF and tells the monitor when the sponsor requires it. The PI remains responsible for the study and stays reachable for questions the covering investigator cannot answer.
5.6.4
Unplanned absence. Where the absence lasts over [DEFAULT: 2 business days], or a participant has a visit, dose or SAE assessment due during it, the Site Director confirms coverage by the named covering investigator the same day and records it on F-705-01. For an absence over 2 business days, or where the sponsor requires notice, the Regulatory Coordinator informs the sponsor within [DEFAULT: 1 business day]. Other short absences are covered by the named covering investigator without a record or notice.
5.6.5
Absence over [DEFAULT: 30 calendar days], planned or unplanned. The PI or Site Director notifies the sponsor and IRB in writing as their requirements specify and decides with the sponsor whether a PI change is needed. The Regulatory Coordinator files the notices and the decision in the ISF. The covering investigator becomes PI only through a formal change under 5.7.
5.6.6
No listed investigator can cover. The PI and Site Director pause investigator-dependent procedures for that study for the absence, unless the sponsor agrees another arrangement in writing. The Regulatory Coordinator tells the sponsor the same business day. A covering investigator is added to the study as in 5.6.2 before that person covers. SAE reporting to the sponsor continues within the required time (SOP-09), and participants needing urgent care are referred to usual medical care. The decision is recorded on F-705-01 and F-306-01.
5.6.7
Other key roles. F-705-01 names a trained, delegated backup for the Regulatory Coordinator, IP Manager, each study's Lead CRC, the Quality Lead and the Site Director. Wherever this SOP names the Site Director, the Site Director's backup acts when the Site Director is unavailable; where the PI is also the Site Director, that backup is not the PI. The backup takes over; where backups cannot cover the workload safely, the Site Director arranges temporary staff or reduces enrollment.
5.7 PI departure and study transfer
5.7.1
A PI who plans to leave, retire or stop serving as PI tells the Site Director at least [DEFAULT: 90 calendar days] before the last working day.
5.7.2
The Regulatory Coordinator notifies each sponsor and IRB in writing within [DEFAULT: 5 business days] of the PI's notice. The sponsor decides whether the study continues under a new PI, transfers to another site or closes at the site (SOP-15).
5.7.3
For a new PI, the Regulatory Coordinator completes, before the departing PI leaves where possible: a new 1572 or investigator agreement sent to the sponsor; the new PI's qualification records (SOP-01) and financial disclosure (SOP-02); IRB approval before the new PI acts as PI (SOP-03); an updated F-302-01 acknowledged by the new PI; any participant notification or re-consent the IRB or sponsor requires (SOP-04); and a CTA amendment if the CTA names the PI.
5.7.4
Before leaving, the departing PI completes outstanding AE and SAE assessments, eligibility sign-offs, EDC signatures and query responses, and holds a handover meeting with the new PI recorded on F-306-01. The Regulatory Coordinator tells the sponsor who is responsible for keeping the essential records (ICH E6(R3) Annex 1, 2.12.13), and the Quality Lead removes system access (SOP-12).
5.7.5
If the PI ends participation without the sponsor's prior agreement, the PI informs the sponsor and IRB with a detailed explanation, informs participants and arranges their therapy and follow-up (ICH E6(R3) Annex 1, 2.6.2; SOP-15).
5.8 Closure or sale of a site or location
5.8.1
The Site Director tells the Quality Lead and PIs once a decision to close, sell or merge is made, engages [LEGAL COUNSEL], and reviews each CTA for assignment, termination and notice terms.
5.8.2
The Regulatory Coordinator notifies in writing each sponsor (as early as the CTA requires and before any public announcement where possible), each IRB as its policy requires, and FDA where the site holds an IND or IDE (SOP-M6, if adopted).
5.8.3
For each study the PI and sponsor decide whether to finish at the site, transfer participants or close the study (SOP-15). Participants transfer only with their agreement; the receiving site obtains its own IRB approval and consent, and records go to it only as the participant's HIPAA authorization allows (SOP-12).
5.8.4
Records in their retention period go to a new custodian under the custody-transfer steps in SOP-12, including the device-only FDA notice under 21 CFR 812.140(e). Records are never abandoned or destroyed because a site closes. Unused IP is returned or destroyed as the sponsor directs (SOP-06), and stored specimens are shipped as directed (SOP-11).
5.8.5
In a sale or merger, the buyer becomes responsible for studies and records only after sponsor agreements, IRB approvals and 1572 or investigator agreement changes are complete; until then the seller remains responsible.
5.9 Annual tabletop test
5.9.1
Once a year at each location, the Quality Lead runs a tabletop test with the Site Director, a PI, the IP Manager and a CRC. Over each [DEFAULT: 2-year] cycle the tests cover a storage unit failure with move to backup storage, an IT outage using downtime forms, and PI unavailability confirming the covering investigator for each active study.
5.9.2
Each test also checks the contact tree, that coolers, packs and data loggers are on hand and within calibration, and that sponsor approvals of backup storage are current. The annual restore test (SOP-12) result is reviewed at the same time.
5.9.3
The Quality Lead records the scenario, participants, results and gaps on F-705-01. Gaps from a test or real event are corrected, with a CAPA under SOP-08 where needed, and results go to the management review (SOP-14).
6. Related Forms and SOPs
- F-705-01 Business Continuity Plan and Emergency Contacts
- F-302-01 Delegation of Authority Log
- F-304-02 Temperature Monitoring Log
- F-304-03 Temperature Excursion Report
- F-306-01 Note to File
- F-308-01 Protocol Deviation Log
- F-309-01 Participant Contact and Retention Log
- F-401-01 Computerized System Inventory and Access Log
- SOP-01 SOP Control, Training and Qualification
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-03 IRB Oversight, Essential Records and Study Activation
- SOP-04 Informed Consent
- SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding
- SOP-06 Investigational Product Management
- SOP-07 Source Documentation and EDC
- SOP-08 Protocol Deviations and CAPA
- SOP-09 Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy)
- SOP-11 Specimens, Equipment and Laboratories
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-14 Quality Control and Quality Review
- SOP-15 Study Closeout
- SOP-M1 Service Providers and Vendors (if adopted)
- SOP-M4 Decentralized Trial Elements (if adopted)
- SOP-M6 Sponsor-Investigator Studies (IND/IDE Holder) (if adopted)
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.60; 21 CFR 812.100 | General responsibilities of investigators |
| 21 CFR 312.62; 21 CFR 812.140 | Investigator records, including 812.140(e) records custody |
| 21 CFR 312.66 | Assurance of IRB review (changes to eliminate apparent immediate hazards) |
| 45 CFR 164.308(a)(7) | HIPAA Security Rule: contingency plan |
| ICH E6(R3) Annex 1, 2.2 | Resources |
| ICH E6(R3) Annex 1, 2.6 | Premature termination or suspension of a trial |
| ICH E6(R3) Annex 1, 2.12.13 | Informing the sponsor of the person responsible for records |
| FDA Guidance (May 2010; Revision 1 draft, May 2021) | Frequently Asked Questions, Statement of Investigator (Form FDA 1572) |
| Reference Edition SOP-705 and SOP-101 | Full text and background |
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.