SOP-200

Study Feasibility and Selection

Number: SOP-200
Category: Start-up and Regulatory
Edition: Reference Edition 1.3
Approx. pages: 7

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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] assesses whether it can conduct a proposed clinical trial, answers sponsor and CRO feasibility questionnaires with data it can support, and makes and records a go/no-go decision. ICH E6(R3) expects the investigator to demonstrate the potential to recruit the agreed number of eligible participants and to have sufficient time, qualified staff and adequate facilities for the duration of the trial. This SOP is how the site produces that evidence before it commits.

2. Scope

This SOP applies to every industry-sponsored, CRO-managed, cooperative group and investigator-initiated study offered to [SITE NAME] at any of its locations, from first contact through the go/no-go decision. It covers feasibility questionnaires, internal feasibility assessment, enrollment estimates and the decision record.

Out of scope: confidentiality agreements, contracts and budgets (SOP-201), coverage analysis (SOP-202), sponsor site qualification visits (SOP-205) and recruitment planning after activation (SOP-300). 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)	Reviews the protocol synopsis or protocol for scientific and medical fit, participant safety and personal capacity. Confirms interest and available time. Approves the enrollment estimate. Signs the go/no-go decision.
Site Director	Owns the feasibility process and the study pipeline. Checks staff capacity, facilities and financial viability. Makes the final go/no-go decision with the PI and records it.
Regulatory Coordinator	Logs incoming opportunities, routes the CDA to SOP-201, and files the completed F-200-01 and decision record.
Clinical Research Coordinator (CRC) or Lead CRC	Reviews visit schedule and procedures for operational burden. Estimates coordinator hours per participant. Identifies procedures, equipment and vendors the site lacks.
Recruitment Specialist	Runs or requests EHR and database queries, reviews referral sources and prior enrollment history for similar studies.
Finance / Contracts Lead	Gives a preliminary view on financial viability (expected per-participant payments, start-up fees, cash flow) before a "go" decision.
Quality Lead	Reviews whether open CAPAs, recent audit findings or inspection history affect the site's ability to take the study.

4. Definitions

Term	Definition
Feasibility questionnaire	A sponsor or CRO form, often online, asking the site to describe its population, experience, capacity and facilities for a proposed study.
Feasibility assessment	The site's internal evaluation of a proposed study, recorded on F-200-01.
Go/no-go decision	The documented decision by the PI and Site Director to pursue or decline a study, with the reasons.
Competing study	Any open or planned study at the site, or at a nearby site the site knows of, that draws on the same participant population or the same staff and equipment.
Enrollment estimate	The number of participants the site expects to randomize or enroll within the sponsor's enrollment period, with the basis for the number.
Screen-fail rate	The proportion of consented participants who do not meet eligibility and are not enrolled.
Preparatory to research	A HIPAA provision (45 CFR 164.512(i)(1)(ii)) that lets a covered entity use or disclose protected health information (PHI) to prepare a research protocol or assess feasibility, with representations from the researcher and no PHI removed from the covered entity.
De-identified data	Health information that meets the HIPAA de-identification standard in 45 CFR 164.514(a) and (b).

5. Procedure

5.1 Intake and logging

5.1.1

The person who receives a study inquiry (email, CRO portal, phone call, sponsor visit) forwards it to the Regulatory Coordinator or to [FEASIBILITY INBOX] within [DEFAULT: 1 business day].

5.1.2

The Regulatory Coordinator logs the opportunity in [STUDY PIPELINE TRACKER] with sponsor, CRO, protocol number, indication, phase, contact, date received and questionnaire due date.

5.1.3

If the sponsor requires a confidentiality agreement before releasing the protocol or synopsis, the Regulatory Coordinator routes it under SOP-201 before any confidential document is opened or circulated.

5.1.4

The Site Director assigns a feasibility owner (usually the Lead CRC or Recruitment Specialist) and sets an internal deadline that leaves the PI at least [DEFAULT: 2 business days] to review before the sponsor due date.

5.2 First screen

5.2.1

The feasibility owner reads the synopsis or protocol and records the basics on F-200-01: indication, phase, design, population, key inclusion and exclusion criteria, visit count and duration, enrollment target and period, IP type and storage, and any special procedures.

5.2.2

The feasibility owner flags any immediate stop factor and sends it to the Site Director and PI. Examples:

the site has no qualified investigator in the required specialty
the protocol requires a facility the site does not have and cannot reliably source (for example inpatient beds, a specific imaging modality, a -80 °C freezer, a DEA registration in the schedule of a controlled-substance IP)
the site already runs a study that would compete directly for the same participants
the sponsor's timeline cannot be met given current IRB, contract and staffing lead times

5.2.3

If a stop factor exists and cannot be solved, the PI and Site Director may decide "no-go" at this stage. The Site Director records the reason on F-200-01 and the feasibility owner replies to the sponsor.

5.3 Patient population: data, not impressions

5.3.1

The Recruitment Specialist or feasibility owner translates the key eligibility criteria into a query that can run against data the site holds: EHR, practice management system, recruitment database, prior study screening logs.

5.3.2

The query uses structured fields where possible (ICD-10 diagnosis codes, age, sex, lab values with dates, active medications, visit dates within a defined look-back window). Criteria that cannot be queried (for example "willing to undergo two biopsies") are listed on F-200-01 as unqueried and are discounted in step 5.6.

5.3.3

Population queries for feasibility produce aggregate counts only. No PHI leaves the site and no PHI is entered in a sponsor or CRO questionnaire. Where staff review individual charts to refine a count, they do so under the HIPAA preparatory-to-research provision and SOP-400 (or, if [SITE NAME] is not a HIPAA covered entity, under the site privacy policy and any [STATE] law in SOP-400), record no identifiers on F-200-01, and follow the single pre-screening rule in SOP-300 Participant Recruitment, Pre-Screening and Advertising, section 5.10. Record review for feasibility under the preparatory-to-research provision (no PHI leaves the covered entity, no contact with the patient) may happen before activation. Any contact with a candidate about the study, or use of recruitment materials, happens only after the IRB approves those materials. A preparatory-to-research representation is a HIPAA representation, not an IRB approval.

5.3.4

The feasibility owner records on F-200-01, for each query:

the data source and the date the query was run
the criteria applied and the look-back period
the count returned
who ran it

5.3.5

If the site depends on referring physicians or partner practices for the population, the feasibility owner records the referral source and the evidence of past referral volume (for example the number of referred participants for comparable studies in the last 12 months). A verbal assurance from a referring practice is recorded as such, not as a patient count.

5.3.6

The feasibility owner pulls enrollment history from comparable completed or ongoing studies at the site: target, actual enrolled, months to enroll, screen-fail rate and main screen-fail reasons.

Network note: In Model N, the network population figure is the sum of each member site's aggregate counts under 5.3.3. N-Affiliated: no PHI moves from a member site to the Network Office or to another member site for feasibility. Chart review under the preparatory-to-research provision stays inside the covered entity that holds the records. Whether the Network Office may run a feasibility query on a member site's data under a business associate agreement is an open question for counsel; until [LEGAL COUNSEL] confirms it in writing, the member site runs its own query and sends only aggregate counts. N-Integrated: where the sites and the network entity are one legal entity and one covered entity, data may be queried across sites within it, but only aggregate counts go to a sponsor. Commonly owned companies that have designated themselves an affiliated covered entity (45 CFR 164.105(b)) may do the same within that designation. Each cross-entity or central data flow is recorded on F-905-01 Cross-Entity Data Flow Register (SOP-905 Network Data, Systems, Privacy and Records Across Sites). 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).

5.4 Competing studies and site capacity

5.4.1

The feasibility owner lists every open or planned study at the site in the same or an overlapping population, with remaining enrollment targets, and records them on F-200-01. Where known, nearby sites running the same protocol or competing protocols are also noted.

5.4.2

The Lead CRC estimates the coordinator workload: hours per screening visit, hours per treatment visit, total visits per participant, and data entry and query burden. The Site Director compares this with current staff allocation and records whether the study can be staffed with existing staff, with planned hires, or not at all. For a study that needs unblinded staff, the Site Director also records whether a qualified unblinded person and a trained backup are available who will not do blinded tasks on that study (SOP-305).

5.4.3

The Site Director confirms that the PI and any Sub-I have the time to perform the protocol's investigator tasks (eligibility review, physical exams, AE assessment, dosing oversight) at the expected enrollment rate, alongside clinical duties and other studies.

5.4.4

The feasibility owner checks facilities and equipment against protocol requirements and records any gap and the plan to close it:

exam rooms, infusion chairs, procedure space, overnight or extended-visit capacity
IP storage (room temperature, refrigerated, frozen) with temperature monitoring, secure storage, controlled substance storage (21 CFR 1301.75) if applicable
specimen processing: centrifuge (refrigerated if required), freezers, dry ice access, shipping (SOP-311)
equipment that needs calibration (ECG, scales, spirometer) (SOP-312)
local laboratory with the correct CLIA certificate type for any testing done on site
imaging, specialist services or vendors the site would need to engage (SOP-105)
systems: internet bandwidth, devices for eCOA, sponsor portals

5.4.5

The feasibility owner records any special population or language requirements (for example Spanish-speaking participants, pediatric participants, participants who need a legally authorized representative) and whether the site has the staff and IRB-approved materials to serve them.

5.5 PI review

5.5.1

The PI reviews the protocol or synopsis and F-200-01 and records on F-200-01:

scientific and medical interest in the study
any participant safety concerns about the design or population
whether the standard-of-care requirements are consistent with how the site's patients are managed
personal availability for the study's duration, including planned absences
any financial or other conflict of interest (SOP-104)

5.5.2

If the PI does not have relevant therapeutic experience, the PI and Site Director record how qualification will be demonstrated (for example a qualified Sub-I, specific training) or decline the study.

5.6 Enrollment estimate

5.6.1

The feasibility owner builds the enrollment estimate from the population data in 5.3, applying explicit, recorded assumptions:

proportion of the queried population likely to meet unqueried criteria
proportion expected to be interested and willing after contact
expected screen-fail rate (from site history on similar studies; where no history exists, the sponsor's projected rate or a conservative assumption recorded as such)
months of active enrollment the site can realistically achieve, allowing for start-up time
share of the population taken by competing studies

5.6.2

The feasibility owner records the estimate as a range (low and expected) with the assumptions, not as a single optimistic number.

5.6.3

The PI approves the estimate. The number the site gives the sponsor must be the approved expected value or lower. Staff must not inflate the estimate to win site selection.

5.7 Financial viability check

5.7.1

Before the go/no-go meeting, the Finance / Contracts Lead reviews any budget information the sponsor has provided (or a typical per-participant amount for the phase and indication) against the estimated staff hours and procedure costs and gives a preliminary view: viable, viable only with negotiation, or not viable.

5.7.2

The detailed budget is built under SOP-201 after a "go" decision. A preliminary "not viable" view is a reason to negotiate or decline, recorded on F-200-01.

5.8 Go/no-go decision

5.8.1

The PI and Site Director review the completed F-200-01 together (in a meeting or by documented email exchange) and decide go, conditional go, or no-go.

5.8.2

The decision record on F-200-01 includes:

the decision and date
the main reasons, citing the population, capacity, competing-study, facility, PI and financial findings
conditions for a conditional go (for example "go if sponsor funds a refrigerated centrifuge" or "go if second CRC hired by [DATE]")
signatures or electronic approvals of the PI and Site Director

5.8.3

The Site Director may override a feasibility owner's recommendation, with the reason recorded. The PI may decline any study for medical, ethical or capacity reasons and the site does not proceed without a willing PI.

5.8.4

A conditional go becomes a go only when the Site Director records on F-200-01 that each condition is met.

5.9.1

The feasibility owner completes the sponsor questionnaire only from the data recorded on F-200-01. Every number entered (patient counts, enrollment estimate, staff numbers, past enrollment performance, equipment) must trace to F-200-01 or a source the site keeps.

5.9.2

Where the questionnaire asks for something the site cannot support with data, the answer says so (for example "estimate based on investigator experience; no structured query available").

5.9.3

The PI or Site Director reviews the completed questionnaire before submission. The feasibility owner saves a copy or export of the submitted answers with F-200-01. If the portal does not allow export, the feasibility owner takes screenshots or keeps a copy of the answers entered.

5.9.4

If the site decides no-go after the sponsor has sent a questionnaire, the feasibility owner tells the sponsor the site is declining, without disclosing confidential information about other studies.

5.10 After selection

5.10.1

If the sponsor selects the site, the Regulatory Coordinator updates [STUDY PIPELINE TRACKER] and start-up proceeds under SOP-201, SOP-202, SOP-203 and SOP-205.

5.10.2

If the protocol changes materially between feasibility and final protocol (for example new exclusion criteria, added visits, a larger enrollment target), the feasibility owner updates F-200-01 and the PI and Site Director confirm the decision still stands.

5.10.3

During the study, the Lead CRC compares actual enrollment with the feasibility estimate at [DEFAULT: quarterly] intervals. The Site Director reviews large gaps and uses the findings to adjust the site's assumptions for future feasibility work.

5.11 Records

5.11.1

The Regulatory Coordinator files F-200-01, query outputs (aggregate counts only), the submitted questionnaire and the decision record in [FEASIBILITY FOLDER LOCATION], which is part of the site's business files. F-200-01 is not filed in the ISF or given to a sponsor, because it holds other sponsors' study information and the site's financial view. For studies that proceed, only the sponsor's own feasibility questionnaire responses are filed in the ISF (SOP-204) or sent to the sponsor.

5.11.2

Feasibility records for declined studies are retained for [DEFAULT: 3 years].

F-200-01 Study Feasibility Assessment
F-104-01 Conflict of Interest and Financial Interest Disclosure
F-902-01 Study Allocation Decision Record (Model N only)
F-905-01 Cross-Entity Data Flow Register (Model N only)
Appendix B Central and Site Responsibility Matrix (Model N only)
SOP-104 Conflict of Interest and Financial Disclosure
SOP-105 Oversight of Service Providers and Vendors
SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
SOP-202 Medicare Coverage Analysis and Research Billing Compliance
SOP-204 Essential Documents and the Investigator Site File
SOP-205 Site Qualification, Initiation and Study Activation
SOP-300 Participant Recruitment, Pre-Screening and Advertising
SOP-305 Randomization, Blinding and Emergency Unblinding
SOP-311 Biological Specimen Collection, Processing and Shipping
SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
SOP-400 Participant Privacy and HIPAA in Research
SOP-902 Network Study Feasibility, Allocation and Central Contracting (Model N only)
SOP-905 Network Data, Systems, Privacy and Records Across Sites (Model N only)

7. References

Reference	Title
ICH E6(R3) Annex 1, 2.1	Investigator Qualifications and Training
ICH E6(R3) Annex 1, 2.2	Investigator Resources
ICH E6(R3) Annex 1, 3.7	Investigator Selection
21 CFR 312.53	Selecting Investigators and Monitors
21 CFR 812.43	Selecting Investigators and Monitors (devices)
45 CFR 164.512(i)	Uses and Disclosures for Research Purposes
45 CFR 164.105(b)	Affiliated covered entities (Model N)
45 CFR 164.514	De-identification of Protected Health Information
21 CFR 1301.75	Physical Security Controls for Practitioners
42 CFR 493	Laboratory Requirements (CLIA)

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.