SOP-205
Site Qualification, Initiation and Study Activation
- Number
- SOP-205
- Category
- Start-up and Regulatory
- Edition
- Reference Edition 1.3
- 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] prepares for and hosts the sponsor's site qualification visit and site initiation visit (SIV), and how the site confirms that every regulatory, contractual, training, supply and system requirement is met before the first study procedure. The control point is the Study Activation Checklist (F-205-01): no participant is consented, screened or treated until it is complete and the sponsor has given written activation.
2. Scope
This SOP applies to every study at [SITE NAME] from selection through activation, and to activation of a new site location or a new PI on an active study. It covers the qualification visit, regulatory packet, SIV, training, receipt of IP and supplies, system access, the activation checklist and sponsor activation.
Out of scope: feasibility (SOP-200), contract and budget terms (SOP-201), coverage analysis (SOP-202), IRB submission steps (SOP-203) and ISF set-up (SOP-204), which this SOP checks but does not repeat. Where a sponsor, CRO or IRB requirement is stricter than this SOP, the site follows the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Attends the qualification visit and SIV. Signs the Form FDA 1572 or investigator agreement, protocol signature page and financial disclosure. Delegates tasks on F-302-01 and confirms staff are trained. Approves activation on F-205-01. |
| Sub-Investigator (Sub-I) | Provides CV, license, training and financial disclosure. Attends the SIV or completes equivalent training before performing study tasks. |
| Regulatory Coordinator | Prepares and submits the regulatory packet, tracks start-up items, maintains F-205-01 and files records in the ISF. |
| Lead CRC | Coordinates the visits, prepares the site tour, builds source documents and study workflows, confirms supplies, equipment and system access, and leads internal study team training. |
| Research Pharmacist or IP Manager | Prepares IP storage and temperature monitoring, receives and checks the first IP shipment, completes IRT and pharmacy training. |
| Finance / Contracts Lead | Confirms the CTA and budget are executed and the coverage analysis is approved, and records them on F-205-01. |
| Site Director | Confirms staffing, space and facilities for the study. Co-approves activation on F-205-01. |
| Quality Lead | Spot-checks F-205-01 for completeness before activation for [DEFAULT: the first study in each new therapeutic area or with a new PI, and a sample of others]. |
4. Definitions
| Term | Definition |
|---|---|
| Site qualification visit | A visit (on site or remote) by the sponsor or CRO before selection to assess the investigator, staff, facilities and population. Also called a pre-study visit (PSV) or site selection visit. |
| Site initiation visit (SIV) | A visit (on site or remote) by the sponsor or CRO, after selection and usually after IRB approval, to train the site on the protocol and study procedures and confirm readiness. |
| Regulatory packet | The set of investigator and site documents the sponsor collects before activation. |
| Form FDA 1572 | Statement of Investigator required of each investigator in a study under an IND (21 CFR 312.53(c)). |
| Investigator agreement | The signed agreement required of each investigator in a significant risk device study under an IDE (21 CFR 812.43(c)). |
| Study activation | The point at which all start-up requirements are met, F-205-01 is approved, and the sponsor has given written notice that the site may begin enrollment. Also called site activation or "green light". |
| Study-specific procedure | Any activity done only because of the study, including research-only tests, eligibility assessments beyond standard care, and IP administration. |
5. Procedure
5.1 Site qualification visit
5.1.1
When the sponsor requests a qualification visit, the Lead CRC schedules it with the PI, Site Director, Regulatory Coordinator and the IP Manager, and records the date on F-205-01.
5.1.2
Before the visit, the Lead CRC prepares from F-200-01:
- the population data and enrollment estimate (aggregate counts only; no PHI)
- staff list with roles, experience and planned study allocation
- list of competing studies (without confidential sponsor details)
- facility information: exam rooms, IP storage and temperature monitoring, specimen processing, freezers, equipment calibration records, local laboratory CLIA certificate and normal ranges
- the site's SOP index (F-100-03) and recent inspection and audit history if requested
5.1.3
During an on-site visit the Lead CRC escorts the visitor, conducts a tour of the areas the study will use, and does not show participant records or other sponsors' confidential materials. For a remote visit, the Lead CRC provides photos or a live video walk-through if requested.
5.1.4
The PI answers questions about medical oversight, time commitment and patient population personally.
5.1.5
The Regulatory Coordinator files the sponsor's visit confirmation and follow-up letter or report in the ISF and gives action items to the owner named in the letter.
5.2 Regulatory packet
5.2.1
After selection, the Regulatory Coordinator collects and sends the regulatory packet the sponsor requests. Typical contents:
- Form FDA 1572 (drug and biologic studies under an IND) listing the PI, Sub-Is, each location where study procedures occur, each laboratory and the IRB; or the signed investigator agreement for IDE device studies
- signed and dated CVs (current within [DEFAULT: 2 years] or per sponsor) and medical licenses for the PI and Sub-Is
- financial disclosure forms for the PI and each Sub-I listed on the 1572 (21 CFR 54); see SOP-104
- GCP and human subjects protection training certificates (SOP-103)
- signed protocol signature page and, where required, IB acknowledgment
- laboratory certificates (CLIA, CAP where applicable), normal ranges and laboratory director CV where required
- IRB information (name, address, compliance statement or registration)
- site information and contact forms
5.2.2
The PI reviews the 1572 before signing and confirms: every person listed in section 6 is someone who will make a direct and significant contribution to the data; every location in sections 3 and 4 is correct; and the PI understands the commitments in section 9. A new signed 1572 is needed only when a new PI takes over the study or a new protocol is added under the IND. For other changes (a Sub-I added, a laboratory or location added, an IRB address change), the Regulatory Coordinator records the change in the study records and tells the sponsor, which may ask for a revised 1572; the FDA Form 1572 FAQs do not require a new form for these changes (SOP-101, 5.2.5).
5.2.3
Before any person performs study tasks, the Regulatory Coordinator confirms that a current debarment, disqualification and exclusion screen is on file for them (SOP-103; SOP-704 Research Misconduct and Fraud Reporting, 5.7). If it is not, the Quality Lead runs it before the person is delegated.
5.2.4
The Regulatory Coordinator files a copy of everything sent in the ISF and records each item on F-205-01.
5.3 Site initiation visit
5.3.1
The Lead CRC schedules the SIV with the sponsor and confirms attendance by the PI, Sub-Is, CRCs, IP Manager and any staff who will perform delegated tasks. The PI attends; if a delegated staff member cannot attend, they complete the sponsor's recorded SIV training or a documented make-up session before performing study tasks.
5.3.2
Before the SIV, the study team reads the protocol, IB, pharmacy manual, laboratory manual and other study manuals provided.
5.3.3
At the SIV, the Lead CRC confirms that the sponsor covers, and records questions and answers on:
- protocol objectives, eligibility, visit schedule and procedures
- informed consent process and approved consent versions
- AE and SAE definitions, assessment and reporting timelines and methods
- IP storage, handling, dispensing, accountability, blinding and unblinding
- randomization and IRT use
- specimen collection, processing and shipping
- EDC, eCOA and other systems
- source document expectations, including what the site will define as source
- monitoring plan and visit frequency
- deviation reporting
5.3.4
Each attendee signs the SIV attendance and training record. The Regulatory Coordinator files it, with the slides and the SIV follow-up letter, in the ISF, and records trial-specific training on F-103-01.
5.3.5
The Lead CRC and PI record the source document plan before first enrollment: for each data point, where it is first recorded (EHR, paper source worksheet, eCOA, direct EDC entry where the protocol allows). The plan is filed in the ISF (SOP-306).
5.4 Delegation and training
5.4.1
The PI assigns study tasks on the delegation of authority log (F-302-01) before any staff member performs them. Delegation is limited to staff qualified by education, training, experience and licensure for the task (SOP-302).
5.4.2
The Lead CRC confirms each delegated person has completed protocol training, system training and any task-specific training (for example IATA shipping, ECG, rating scales) and that it is recorded on F-103-01 before their delegation start date.
5.5 IP, supplies, equipment and systems
5.5.1
The IP Manager confirms that IP storage is ready and monitored (SOP-304), receives the first shipment, checks it against the shipping record, checks temperature data for the shipment, acknowledges receipt in IRT or as the sponsor requires, and records receipt on F-304-01. Temperature excursions on receipt are handled under SOP-304 and the IP is quarantined until the sponsor releases it.
5.5.2
The Lead CRC confirms receipt of laboratory kits (with expiry dates checked), specimen supplies, shipping materials, eCOA devices and other study supplies, and records it on F-205-01.
5.5.3
The Lead CRC confirms study equipment is calibrated and within its calibration date (SOP-312), and that any sponsor-provided equipment is logged on F-312-01.
5.5.4
The Lead CRC confirms every delegated user has active access to EDC, IRT, eCOA, the safety portal, the central laboratory portal and other study systems with their own credentials, and records system access on F-401-01. Shared logins are not allowed.
5.6 Study Activation Checklist (F-205-01)
5.6.1
The Regulatory Coordinator maintains F-205-01 throughout start-up. Before activation, each item is marked complete with the date and the location of the record, or marked not applicable with a reason. Minimum items:
- IRB approval of the protocol, consent form(s), recruitment materials and participant materials, with the approval letter filed (SOP-203)
- local IRB, reliance agreement or institutional acknowledgment, where required
- executed CTA and budget (SOP-201)
- approved coverage analysis and billing grid, or the no-billing short form (SOP-202)
- signed Form FDA 1572 or investigator agreement, filed and sent to sponsor
- financial disclosure forms for all investigators listed
- signed protocol signature page
- CVs, licenses and GCP training for all investigators and delegated staff
- debarment and exclusion checks for all study staff
- delegation of authority log signed by the PI (F-302-01)
- SIV completed and protocol training recorded for all delegated staff (F-103-01)
- IP received, stored under monitored conditions and released for use, with accountability log started (F-304-01, F-304-02); or, where the sponsor ships IP only after first consent or randomization, the sponsor's IP shipping trigger and lead time documented, with receipt and release under SOP-304 required before the first dose
- for controlled-substance IP, DEA registration and any state controlled substance registration in place for each storage location (SOP-304, 5.9.1)
- emergency unblinding procedure available to the investigator (blinded studies) (SOP-305)
- blinded studies: blinded and unblinded roles named, each with a backup, and the separation of unblinded records and IP areas in place (SOP-305)
- laboratory kits and study supplies received and in date
- laboratory certification and normal ranges filed
- study equipment calibrated
- system access for all delegated users (F-401-01)
- source document plan and study-specific source worksheets ready (SOP-306)
- ISF set up and index current (F-204-01)
- study QC plan approved on F-700-01 (SOP-700, 5.2)
- study pages or trackers opened for AEs, SAEs and pregnancies (F-500-01, F-501-01, F-503-01)
- the IRB's reportable-event categories and reporting windows for the study recorded for use with F-502-01 (SOP-502)
- record retention period for the study recorded from the CTA, sponsor instructions and regulations (SOP-402)
- recruitment plan and approved materials ready (SOP-300)
- participant payment process set up, if applicable (SOP-310)
- written sponsor activation (green light) received
5.6.2
The Lead CRC and Regulatory Coordinator review the completed checklist. For the studies named in section 3, the Quality Lead spot-checks F-205-01 for completeness before PI approval and records the check on the form. The PI and Site Director sign or electronically approve F-205-01 to record that the site is ready.
5.6.3
The sponsor's written activation notice is filed in the ISF. Activation by the sponsor without a complete F-205-01 does not authorize the site to start; the open items are closed first.
5.7 No study procedures before activation
5.7.1
No staff member consents a participant, performs a study-specific procedure, randomizes, or dispenses IP before F-205-01 is approved and sponsor activation is received.
5.7.2
Pre-screening follows the single rule in SOP-300 Participant Recruitment, Pre-Screening and Advertising, section 5.10. Record review for feasibility under the HIPAA preparatory-to-research provision (no PHI leaves the covered entity, no contact) may happen before activation; a preparatory-to-research representation is a HIPAA representation, not an IRB approval. Any contact with a candidate about the study, or use of IRB-approved recruitment materials, happens only after the IRB approves those materials. Pre-screening logs (F-300-01) start on or after the IRB approval date for the study. Nothing that requires consent happens before activation, and pre-screening does not include study-specific procedures.
5.7.3
Any study procedure performed before activation is recorded as a deviation under SOP-308 and reported to the sponsor and, if required, the IRB.
5.8 Changes after activation
5.8.1
A PI change requires a new 1572 or investigator agreement. A new site location or laboratory requires notice to the sponsor (with a revised 1572 if the sponsor asks for one). Each also requires IRB approval where the IRB requires it (SOP-203) and sponsor confirmation before study activities occur at the new location or under the new PI. The Regulatory Coordinator completes a new F-205-01 limited to the changed items.
5.8.2
A new Sub-I or delegated staff member does not perform study tasks until their CV, license, training, financial disclosure (if an investigator), debarment and exclusion screen, sponsor notice of the 1572 change (if listed) and delegation are complete.
5.8.3
Protocol amendments are implemented only after IRB approval, staff training on the change, and any budget, coverage analysis and billing grid updates (SOP-201, SOP-202).
5.9 Records
5.9.1
The Regulatory Coordinator files F-205-01, the qualification visit and SIV letters and reports, training records, the regulatory packet and the sponsor activation notice in the ISF under SOP-204.
6. Related Forms and SOPs
- F-205-01 Study Activation Checklist
- F-100-03 SOP Master Index and Review Schedule
- F-103-01 Staff Training Log
- F-200-01 Study Feasibility Assessment
- F-204-01 Investigator Site File Index
- F-300-01 Pre-Screening Log
- F-302-01 Delegation of Authority Log
- F-304-01 Investigational Product Accountability Log
- F-304-02 Temperature Monitoring Log
- F-312-01 Equipment Inventory and Calibration Log
- F-401-01 Computerized System Inventory and Access Log
- F-500-01 Adverse Event Assessment Worksheet
- F-501-01 SAE Reporting Tracker
- F-502-01 Reportable New Information Assessment
- F-503-01 Pregnancy Report Tracker
- F-700-01 Internal QC Review Checklist
- Appendix B Central and Site Responsibility Matrix (Model N only)
- SOP-103 Staff Qualification, Training and Training Records
- SOP-104 Conflict of Interest and Financial Disclosure
- SOP-200 Study Feasibility and Selection
- SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
- SOP-202 Medicare Coverage Analysis and Research Billing Compliance
- SOP-203 IRB Submissions, Approval and Continuing Oversight
- SOP-204 Essential Documents and the Investigator Site File
- SOP-300 Participant Recruitment, Pre-Screening and Advertising
- 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-310 Participant Payments and Reimbursement
- SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
- SOP-402 Record Retention, Archiving and Destruction
- SOP-500 Adverse Event Identification, Assessment and Recording
- SOP-502 Unanticipated Problems and Reportable New Information
- SOP-700 Internal Quality Control and Quality Assurance Audits
- SOP-704 Research Misconduct and Fraud Reporting
- SOP-901 Member Site Onboarding, Integration and Exit (Model N only)
- SOP-902 Network Study Feasibility, Allocation and Central Contracting (Model N only)
- SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.53 | Selecting Investigators and Monitors (Form FDA 1572) |
| 21 CFR 312.60 to 312.69 | Responsibilities of Investigators (drugs and biologics) |
| 21 CFR 812.43 | Selecting Investigators and Monitors (devices) |
| 21 CFR 812.100 to 812.150 | Responsibilities of Investigators (devices) |
| 21 CFR 54 | Financial Disclosure by Clinical Investigators |
| 21 CFR 56.103 | Circumstances in Which IRB Review Is Required |
| ICH E6(R3) Annex 1, 2.1 to 2.3 | Investigator Qualifications and Training; Resources; Responsibilities |
| ICH E6(R3) Annex 1, 2.4.2 | Communication with IRB/IEC (approval before initiating the trial) |
| ICH E6(R3) Annex 1, 2.12.2 | Records (definition of source records before starting the trial) |
| ICH E6(R3) Appendix C | Essential Records for the Conduct of a Clinical Trial |
| 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 (2009) | Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects |
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