SOP-705

Business Continuity and Emergency Preparedness

Number: SOP-705
Category: Quality Assurance
Edition: Reference Edition 1.3
Approx. pages: 9

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[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.

On this page

1. Purpose
2. Scope
3. Responsibilities
4. Definitions
5. Procedure
6. Related Forms and SOPs
7. References

1. Purpose

This SOP describes how [SITE NAME] plans for and responds to events that disrupt study conduct, so that participants stay safe, investigational product (IP) and specimens are protected, records and data are preserved, and studies continue or are transferred in an orderly way.

2. Scope

This SOP applies to all studies, locations and staff of [SITE NAME]. It covers:

power loss
failure of IP or specimen refrigerators and freezers
IT and electronic system outages
severe weather, facility damage and loss of access to a location
pandemics and other public health emergencies
absence of key people, including PI coverage, planned PI departure and transfer of studies to another PI
closure or sale of a site or location, including transfer of records and participants

It does not cover life-safety emergencies for people in the building (fire, medical emergencies, active threat), which follow the facility emergency plan at [FACILITY EMERGENCY PLAN LOCATION], or individual participant medical emergencies, which follow the protocol and SOP-501 Serious Adverse Event and Expedited Safety Reporting.

Where the protocol, sponsor, IRB or clinical trial agreement (CTA) sets a stricter requirement, follow it.

3. Responsibilities

Role	Responsibilities
Site Director	Owns the business continuity plan, declares a continuity event, makes resource decisions, leads communication with sponsors for site-wide events, and leads site closure or sale planning.
Quality Lead	Maintains F-705-01, coordinates the annual test, records events and lessons learned, and opens CAPAs under SOP-703.
Principal Investigator (PI)	Decides on participant safety measures, arranges investigator coverage, and notifies sponsors and IRBs of events affecting their studies.
Sub-Investigator (Sub-I)	Provides investigator coverage when named on F-705-01 and listed on the Form FDA 1572 or device investigator agreement for the study.
Research Pharmacist or IP Manager	Protects IP during cold chain events, manages backup storage and documents excursions under SOP-304.
Regulatory Coordinator	Sends sponsor and IRB notifications and manages regulatory changes for PI changes and site transfers.
Lead CRC / Clinical Research Coordinator (CRC)	Contacts participants, reschedules visits, uses downtime procedures, and transcribes downtime records.
[IT SUPPORT PROVIDER]	Restores systems, maintains backups and supports the annual restore test.
All Research Staff	Know where F-705-01 is kept, keep their contact details current, and follow this SOP during an event.

4. Definitions

Term	Definition
Business continuity plan (BCP)	The site's documented plan for continuing or recovering critical study activities during and after a disruption, recorded on F-705-01.
Continuity event	Any event that disrupts or threatens study activities enough to activate this SOP.
Critical activities	Activities that must continue or be restored quickly to protect participants and data: safety follow-up and SAE reporting, IP storage and dosing, emergency unblinding, protocol-required visits within windows, specimen storage, and record security.
Downtime procedure	A pre-approved manual method to perform a task when an electronic system is unavailable, with later entry into the system.
Contact tree	The list of people and the order in which they are contacted during an event, in F-705-01.
Covering investigator	A qualified investigator, listed on the Form FDA 1572 or device investigator agreement for the study, who handles investigator duties during the PI's absence.
Custody of records	Responsibility for keeping essential records for the required retention period.

5. Procedure

5.1 The business continuity plan (F-705-01)

5.1.1

The Site Director and Quality Lead prepare F-705-01 Business Continuity Plan and Emergency Contacts for each location before the first study starts there, and review it at least [DEFAULT: annually and after any continuity event, change of location, new freezer or new key system].

5.1.2

F-705-01 contains:

the contact tree: staff, PIs and Sub-Is with mobile numbers; [IT SUPPORT PROVIDER]; building management; utility company; temperature monitoring alarm service; backup IP and specimen storage location; courier; [LEGAL COUNSEL]; insurance carrier
the list of active studies with sponsor, CRO, monitor, IRB, IxRS and emergency unblinding contacts
the list of critical activities for each location and who is responsible for each
backup storage arrangements for IP and specimens (section 5.3)
list of electronic systems with their downtime procedure and owner (section 5.4)
investigator coverage arrangements (section 5.7)
the location of paper downtime forms, a printed copy of F-705-01, and emergency supplies (flashlights, coolers, temperature data loggers, dry ice supplier)

5.1.3

A printed copy of F-705-01 is kept at each location in [F-705-01 PRINTED COPY LOCATION], and a current electronic copy is available to the Site Director, Quality Lead and PIs off site. The Quality Lead updates the contact tree at least [DEFAULT: quarterly].

5.1.4

F-705-01 includes participant contact details only by reference to the secure system where they are kept. It does not hold participant identifiers.

5.2 Activating the plan and communication

5.2.1

Any staff member who becomes aware of a continuity event informs the Site Director (or the next person on the contact tree) immediately, and acts first to protect people, then IP and specimens, then records.

5.2.2

The Site Director declares a continuity event, activates the contact tree and assigns tasks.

5.2.3

The PI (or covering investigator) decides on participant safety measures for each study: contacting participants who have visits due, safety follow-up, IP supply for participants at home, and emergency unblinding access.

5.2.4

The Regulatory Coordinator notifies each affected sponsor or CRO of events that affect study conduct within [DEFAULT: 1 business day], or sooner if the protocol or CTA requires, and notifies the IRB where the IRB's policy requires, within the IRB's own reporting window (SOP-502).

5.2.5

The Quality Lead records the event, actions taken, and its effect on studies in the event section of F-705-01. Missed visits, out-of-window visits and other deviations are recorded on F-308-01 Protocol Deviation Log under SOP-308 Protocol Deviations and Noncompliance.

5.3 Power loss and refrigerator or freezer failure

5.3.1

Each IP and specimen refrigerator and freezer has continuous temperature monitoring with an alarm that notifies on-call staff outside business hours [DEFAULT: alarm with remote notification to at least two people], as described in SOP-304 Investigational Product Management and SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements.

5.3.2

The Site Director records on F-705-01 whether each storage unit is on backup power (generator or uninterruptible power supply) and for how long.

5.3.3

The site has a written arrangement for backup storage at [BACKUP STORAGE LOCATION] (for example, another site location, a pharmacy, or a storage vendor), with equivalent temperature control and monitoring and restricted access. Arrangements with an outside party are covered by an agreement under SOP-105 Oversight of Service Providers and Vendors. IP is moved to a backup location only if the sponsor has approved that location for the study's IP before use; the Regulatory Coordinator records each study's approval on F-705-01. Where a sponsor has not approved a backup location, the IP Manager contacts the sponsor at the time of the event before moving IP, unless waiting would put the IP out of range, in which case the move is made and reported to the sponsor the same day.

5.3.4

When a unit fails or power is lost:

The person responding keeps the unit closed to hold temperature and checks the current reading.
If the temperature is expected to leave range before power or the unit is restored [DEFAULT: or the outage is expected to last more than 1 hour], the IP Manager, or any staff member delegated IP tasks on F-302-01 and trained under SOP-304 when the IP Manager cannot be reached, moves IP and specimens to the backup unit or location, in validated or pre-conditioned coolers with a temperature data logger, keeping blinded and study-specific IP separated and labeled.
The person who moved the IP records the move (who moved it, date, times, items, temperatures before and after) on F-304-02 Temperature Monitoring Log.

5.3.5

Any IP that went out of range is quarantined and documented on F-304-03 Temperature Excursion Report. It is not dispensed until the sponsor confirms in writing that it may be used (SOP-304). Specimen excursions are documented and reported to the sponsor or central laboratory under SOP-311 Biological Specimen Collection, Processing and Shipping.

5.3.6

For power loss affecting other activities, the Site Director decides whether to continue visits. Procedures that need powered equipment (ECG, centrifuge, infusion pumps, computers) are rescheduled within protocol windows where possible.

5.4 IT and electronic system outages

5.4.1

For each electronic system used for study conduct (EHR, eSource, EDC, eConsent, eISF, IxRS, ePRO, temperature monitoring, email), F-705-01 records the system owner (site or sponsor), the support contact, and the downtime procedure. Site systems are also listed on F-401-01 Computerized System Inventory and Access Log (SOP-401 Computerized Systems and Electronic Records).

5.4.2

Downtime procedures include:

Source and EHR: paper source templates or blank progress note forms kept at [DOWNTIME FORMS LOCATION]. Paper records completed during downtime are original source. They are entered into the electronic system after recovery, attributed to the person who entered them, dated at the time of entry, and the paper is retained, as described in SOP-306 Source Documentation and Data Integrity (ALCOA+).
eConsent: the current IRB-approved paper version of the consent form, if the IRB and sponsor have approved its use, following SOP-301 Informed Consent Process and Documentation. If no approved paper version exists, consent is postponed.
EDC: data entry waits until the system is restored. The CRC records the outage on F-306-01 Note to File if entry timelines are missed.
IxRS (randomization and IP assignment): the sponsor's helpdesk or manual backup process as described in the study manual. If none is available, randomization waits. Emergency unblinding follows SOP-305 Randomization, Blinding and Emergency Unblinding, including the sponsor's backup unblinding route.
Safety reporting: if the sponsor's electronic SAE system is down, the SAE is reported by the sponsor's backup method (fax, email or phone) within the required time (SOP-501).
Temperature monitoring: manual readings at least [DEFAULT: at the start and end of each business day, and daily on non-business days] on F-304-02 until monitoring is restored.

5.4.3

[IT SUPPORT PROVIDER] keeps backups of site-controlled electronic records and restores them within the recovery time recorded on F-705-01: site-controlled systems within [DEFAULT: 1 business day]; vendor-hosted systems within the time in the vendor's agreement (SOP-401). Backup and contingency planning for systems holding protected health information also meet the HIPAA Security Rule contingency plan standard (45 CFR 164.308(a)(7)).

5.4.4

A suspected cyberattack or loss of data is also handled as a privacy incident under SOP-400 Participant Privacy and HIPAA in Research.

5.5 Severe weather, facility damage and loss of access

5.5.1

When severe weather or another hazard is forecast, the Site Director decides by [DEFAULT: 6:00 pm the previous day] whether to close a location, and the contact tree is activated.

5.5.2

Before a forecast event, the CRCs review participants due for visits and, with the PI, decide for each:

move the visit earlier or later within the protocol window
convert to a remote visit where the protocol permits (SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP))
provide extra IP supply only where the protocol and sponsor allow

5.5.3

Staff contact affected participants, record contacts on F-309-01 Participant Contact and Retention Log, and give them the site's emergency contact number.

5.5.4

If a location is damaged or inaccessible, the Site Director decides, with the PIs and sponsors, whether to move study activities to another location. A new location may require sponsor approval, IRB notification or approval, and a change to the Form FDA 1572 information (recorded and sent to the sponsor per SOP-302 5.5.2) (section 5.9 of this SOP applies to any long-term move). IP and records are moved only under documented chain of custody.

5.6 Pandemic and public health emergencies

5.6.1

The Site Director monitors public health orders and sponsor and FDA communications, and applies infection-control measures for staff and participants as required by local public health authorities.

5.6.2

Changes to study conduct (remote visits, local laboratory use, direct-to-participant IP shipment, alternative consent methods) are made only as the sponsor and IRB approve, except changes needed to eliminate an apparent immediate hazard to participants. Those may be made at once and reported as described in SOP-308.

5.6.3

Each change and its effect on each participant is documented, and the PI keeps the sponsor informed of staff capacity to support studies.

5.6.4

The Site Director plans for staff absence by cross-training (section 5.7) and pausing new enrollment where capacity cannot cover active participants safely.

5.7 Key person absence and PI coverage

5.7.1

The Quality Lead keeps, on F-705-01, a backup for each key role: PI (covering investigator per study), Regulatory Coordinator, IP Manager, Lead CRC for each study, Quality Lead and Site Director. Backups are trained and delegated on F-302-01 Delegation of Authority Log for the tasks they would cover (SOP-302 Delegation of Authority).

5.7.2

Planned PI absence. SOP-101 5.13 holds the site's single rule for PI absence and coverage (who may cover, the coverage note, and when the sponsor and IRB are told). This section covers only continuity mechanics. The Quality Lead records the covering investigator for each study on F-705-01, and the PI confirms the covering investigator is available for safety questions, eligibility review and SAE assessment for the absence.

5.7.2.1

Study with no listed Sub-I. If no investigator listed for the study can cover, the PI and Site Director pause investigator-dependent procedures for that study (consent by an investigator, eligibility confirmation, randomization, IP dosing and AE causality assessment) for the absence, unless the sponsor agrees another arrangement in writing. The Regulatory Coordinator tells the sponsor the same business day. A qualified covering investigator is arranged and added to the study (1572 or investigator records, and F-302-01) before that person covers. SAE reporting to the sponsor continues within the required time (SOP-501), and participants needing urgent care are referred to usual medical care. The decision is recorded on F-705-01 and F-306-01 Note to File.

5.7.3

The PI remains responsible for the study during a planned absence and stays reachable for questions the covering investigator cannot answer.

5.7.4

Unplanned PI absence. The Site Director confirms coverage by the named covering investigator the same day and records it on F-705-01, and the Regulatory Coordinator informs the sponsor. Where no listed investigator can cover, 5.7.2.1 applies. Longer absences follow SOP-101 5.13.4, and a PI change follows section 5.8.

5.7.5

Other key roles. The named backup takes over. The Site Director arranges temporary staffing or reduces enrollment where backups cannot cover the workload safely.

5.8 Planned PI departure and transfer of studies

5.8.1

A PI who plans to leave the site, retire or stop serving as PI tells the Site Director as early as possible [DEFAULT: at least 90 calendar days before the last working day].

5.8.2

The Site Director and Regulatory Coordinator notify each sponsor promptly and in writing. The sponsor decides whether the study continues at the site under a new PI, transfers to another site, or closes at the site.

5.8.3

When a new PI takes over, before the departing PI leaves where possible, the Regulatory Coordinator completes:

a new Form FDA 1572 signed by the new PI (drug and biologic studies) or a new signed investigator agreement (device studies), sent to the sponsor
new PI CV, license and training records (SOP-103)
financial disclosure for the new PI (SOP-104 Conflict of Interest and Financial Disclosure)
IRB submission of the PI change, with approval before the new PI acts as PI (SOP-203 IRB Submissions, Approval and Continuing Oversight)
updated F-302-01 Delegation of Authority Log, with the new PI's acknowledgment of current delegations
any participant notification or re-consent the IRB or sponsor requires (SOP-301)
CTA amendment if the CTA names the PI (SOP-201)

5.8.4

Before leaving, the departing PI completes outstanding investigator tasks: AE and SAE assessments, eligibility sign-offs, EDC signatures and query responses for their period, and a handover meeting with the new PI, documented in a Note to File.

5.8.5

If the departing PI is moving to another site and the sponsor wants participants to transfer with them, section 5.9.4 applies.

5.9 Closure or sale of a site or location

5.9.1

The Site Director informs the Quality Lead and PIs once a decision to close, sell or merge a site or location is made, and engages [LEGAL COUNSEL]. Closure or sale is planned per study with each sponsor.

5.9.2

The Site Director or Finance / Contracts Lead reviews each CTA for assignment, termination and notice clauses. Most CTAs require sponsor consent to assign the agreement to a buyer. The Regulatory Coordinator notifies, in writing:

each sponsor or CRO, as early as the CTA requires and before any public announcement where possible
each IRB, as the IRB's policy requires, including any change of PI, site name or location
FDA, where the site holds an IND or IDE as sponsor-investigator (SOP-800 Sponsor-Investigator Responsibilities (IND/IDE Holder)), or where required for device record custody (section 5.9.5)

5.9.3

For each study, the PI and sponsor decide whether to complete the study at the site before closure, transfer participants to another site, or close the study at the site (SOP-601 Study Closeout).

5.9.4

Transfer of participants. Participants transfer to another site only with their agreement. The receiving site obtains IRB approval and consents the participant under its own approved consent form. Participant records go to the receiving site only as authorized by the participant's HIPAA authorization or a new authorization (SOP-400). Copies of transferred participants' records needed for continuing care and safety follow-up are sent to the receiving investigator, and the originals stay with the record custodian.

Network note: Transfer of a participant to another network site follows 5.9.4 in both variants, because the receiving site is a separate investigator site with its own IRB approval, consent and 1572. N-Integrated: where both sites are the same legal entity, moving records within that one covered entity is a use, still limited to the minimum necessary. N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1). N-Affiliated: it is a disclosure between entities and needs a permitted pathway (SOP-905). A member site leaving the network follows SOP-901.

5.9.5

Transfer of records custody. Records within their retention period are transferred to a new custodian (for example, the buyer, the PI's new site, or a records storage vendor) under SOP-402, section 5.6, which covers the written custody agreement, sponsor notification, the device-only FDA notice under 21 CFR 812.140(e), and chain of custody on F-402-01 Record Archiving and Retrieval Log. Records are never abandoned or destroyed because a site closes.

5.9.6

IP and specimens. Unused IP is returned to the sponsor or destroyed as the sponsor directs, and accountability is reconciled (SOP-304). Stored specimens are shipped as the sponsor or laboratory directs (SOP-311).

5.9.7

Sale of the site. In a sale or merger, the buyer becomes responsible for studies and records only after the sponsor agreements, IRB approvals and Form FDA 1572 or investigator agreement changes are complete. Until then, the seller remains responsible. HIPAA and state law requirements for transferring participant records in a sale are confirmed with [LEGAL COUNSEL].

5.10 Annual test and review

5.10.1

The Quality Lead arranges a test of the plan at least [DEFAULT: annually] at each location. Over each [DEFAULT: 2-year] cycle the tests cover:

the contact tree (call or message test with response times)
a refrigerator or freezer failure scenario, including alarm notification and move to backup storage
an IT outage scenario, including use of downtime forms and a backup restore test with [IT SUPPORT PROVIDER]
a PI unavailability scenario, confirming covering investigator arrangements for each active study

5.10.2

The test may be a tabletop exercise or a live drill. The Quality Lead records the scenario, participants, results and gaps on F-705-01.

5.10.3

Gaps found in a test or real event are corrected, and a CAPA is opened under SOP-703 Corrective and Preventive Action (CAPA) where needed. Test results go to management review under SOP-700.

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
F-402-01 Record Archiving and Retrieval Log
SOP-101 Roles and Responsibilities of the Principal Investigator
SOP-105 Oversight of Service Providers and Vendors
SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
SOP-203 IRB Submissions, Approval and Continuing Oversight
SOP-301 Informed Consent Process and Documentation
SOP-302 Delegation of Authority
SOP-304 Investigational Product Management
SOP-305 Randomization, Blinding and Emergency Unblinding
SOP-306 Source Documentation and Data Integrity (ALCOA+)
SOP-308 Protocol Deviations and Noncompliance
SOP-311 Biological Specimen Collection, Processing and Shipping
SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP)
SOP-400 Participant Privacy and HIPAA in Research
SOP-401 Computerized Systems and Electronic Records
SOP-402 Record Retention, Archiving and Destruction
SOP-501 Serious Adverse Event and Expedited Safety Reporting
SOP-601 Study Closeout
SOP-703 Corrective and Preventive Action (CAPA)
SOP-800 Sponsor-Investigator Responsibilities (IND/IDE Holder)
F-904-01 Shared Staff Assignment and Credentialing Log (Model N only)
SOP-900 Network Governance, SOP Hierarchy and Local Addenda (Model N only)
SOP-901 Member Site Onboarding, Integration and Exit (Model N only)
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 312.60	General responsibilities of investigators
21 CFR 312.62	Investigator recordkeeping and record retention
21 CFR 312.66	Assurance of IRB review (changes to eliminate apparent immediate hazards)
21 CFR 812.140	Records (devices), including 812.140(d) retention period and 812.140(e) records custody
45 CFR 164.308(a)(7)	HIPAA Security Rule: contingency plan
ICH E6(R3) Annex 1, 2.2	Resources
ICH E6(R3) Annex 1, 2.10	Investigational Product Management
ICH E6(R3) Annex 1, 2.12.12 and 2.12.13	Retention of essential records; informing the sponsor of the person responsible for records
ICH E6(R3) Annex 1, 4.3	Computerised Systems
FDA Guidance (May 2010; Revision 1 draft, May 2021)	Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions, Statement of Investigator (Form FDA 1572)
FDA Guidance (Sept 2024)	Conducting Clinical Trials With Decentralized Elements

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.