Resource and infrastructure evaluation: staff, space, equipment, and time

The arithmetic of honest feasibility

You have one coordinator -- yourself. The investigator is available Wednesday afternoons, half the time. The exam room you use for research visits is shared with the pulmonology clinic. And the pharmacy refrigerator, the one that stores investigational product for two existing studies, is full.

Now the sponsor asks: can your site conduct a 52-week study with bi-weekly infusion visits and pharmacokinetic sampling at eight timepoints?

The answer is not "yes" or "no." The answer is arithmetic. How many hours of coordinator time does each participant require, and do you have those hours? How many infusion chairs does the protocol demand simultaneously, and how many do you have? Where will the investigational product be stored, and is there capacity? What happens to your workload in Month 6 when you have 12 active participants, each needing a two-hour infusion visit every 14 days?

I have watched sites accept studies they could not resource. The consequences are predictable and painful: missed visit windows, protocol deviations, exhausted staff, data quality problems, and -- most seriously -- compromised participant safety. ICH E6(R3), Section 2.2.2, is unambiguous: "The investigator should have sufficient time, an adequate number of available and qualified staff, and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely." That sentence contains four requirements -- time, staff, facilities, and duration. This lesson teaches you how to evaluate each one honestly.

The previous lesson asked whether your site has the patients. This lesson asks whether your site has everything else.

Staff assessment: who is doing the work, and when?

Staff assessment is where feasibility gets personal. The protocol describes procedures. The visit schedule describes frequency. But someone has to perform those procedures on that schedule, and the question of who -- and whether they are available -- is the difference between a study that runs smoothly and one that collapses under its own weight.

The most common staffing error I see in feasibility is treating staff as a binary: "Do we have a coordinator? Yes. Then we can do the study." That is like asking whether a restaurant can serve 200 dinners because it has a chef. The question is not whether you have the role filled. The question is whether the person in that role has the hours available, given everything else they are already doing.

Coordinator time per participant. Start here, because this is where the greatest volume of work lands. Pull the visit-by-visit workflow you developed during the operational protocol review (Module 1, Lesson 2). For each visit type, estimate the coordinator time required -- not just the time the participant is physically present, but the total work time including preparation, conduct, documentation, and follow-up.

Investigator availability. The investigator does not need to be present for every visit, but the protocol will specify activities that require physician involvement: informed consent discussions (in many institutional policies), physical examinations, adverse event assessments, eligibility adjudication, and clinical decision-making for dose modifications or study discontinuation. Review the protocol to identify which visit types require the investigator and how much time each requires.

Then map those requirements against the investigator's actual availability. Not their theoretical availability -- their real schedule, accounting for clinical duties, administrative responsibilities, other active studies, teaching obligations, and the reality that most investigators in community or academic settings do not have protected research time. If the investigator is available for research two afternoons per week, and the protocol requires investigator assessments at every bi-weekly visit, you need to know whether those assessments can be reliably scheduled within those two windows. When enrollment reaches 10 or 12 participants, can the investigator see three or four of them in a single afternoon?

Many protocols require nursing procedures -- intravenous infusions, blood draws, vital sign monitoring, ECG acquisition -- that coordinators may not be qualified or authorized to perform. Identify which protocol procedures require nursing support, estimate the time per visit, and determine whether a dedicated research nurse is available or whether you will be drawing from the clinical nursing pool. Shared nursing resources are inherently less reliable: a nurse pulled from a clinical unit for a research infusion may be recalled if a clinical emergency arises.

Space evaluation: where does the work happen?

Space is the resource that sites are most inclined to treat as infinitely flexible. "We will find a room." "We can use the conference room if we need to." "The infusion area can accommodate one more chair." These responses share a common flaw: they are solutions offered before the problem has been quantified.

The space evaluation asks a specific question: for each activity the protocol requires, where will it occur, and is that space available when you need it?

Dedicated versus shared research space. Some sites have dedicated research clinics or research wings -- space that is allocated to clinical trials and not subject to competing clinical demands. If your site has this, the space evaluation is simpler: you need to confirm that the dedicated space has the capacity for the new study's visit volume in addition to existing studies.

Most sites, however, conduct research in shared clinical space. The exam room you use for study visits is also used for clinical patients. The infusion bay accommodates both research and clinical infusions. The specimen processing area serves the laboratory, not the research department. Shared space means your access is not guaranteed. It means scheduling conflicts. And it means that a busy clinical day can displace your research visits.

Participant waiting areas and privacy. This is a detail that less experienced coordinators overlook. Research participants often arrive before their scheduled visit time, wait during specimen processing, or stay for post-dose observation. Where do they wait? Is there seating? Is the area separate from clinical waiting areas, or will research participants in a depression trial be sitting in the endocrinology waiting room for three hours? Privacy matters, not just as a courtesy, but because some protocols involve sensitive health information that participants may not want disclosed by their physical presence in a particular clinical area.

IP storage specifics. Beyond the general storage question, consider the volume. A 52-week study for 15 participants with bi-weekly dispensing might require storage for dozens of cartons of IP at any given time, depending on the shipment schedule. The protocol or pharmacy manual will specify the anticipated IP volume. If the sponsor ships in bulk quarterly, you need enough storage to accommodate the maximum inventory between shipments. If the sponsor ships per-participant kits, the storage volume is lower but the receipt and processing frequency is higher.

Equipment assessment: what you need, what you have, and what state it is in

Equipment assessment is deceptively simple on the surface -- does the site have the equipment the protocol requires? -- but the details matter more than the inventory list suggests. Having an ECG machine is not the same as having a 12-lead ECG machine that is calibrated, maintained, available during your visit windows, and not already scheduled wall-to-wall for existing studies.

Step 1: Identify what the protocol requires. Walk through the visit schedule and list every piece of equipment referenced in the protocol procedures. This is not limited to major devices. A study that requires spirometry needs a spirometer. A study that requires retinal imaging needs a fundus camera. But a study that requires timed blood draws at 0, 15, 30, 60, and 120 minutes post-dose needs a centrifuge, a timer, a calibrated thermometer for the water bath or heating block, cryovials, pipettes, and a freezer -- not just "specimen collection supplies."

For each piece of equipment, confirm that it exists at your site. This sounds obvious, but I have seen feasibility assessments proceed to contract negotiation before anyone verified whether the site had a specific device. Confirm physical location, current condition, and whether it is owned by the institution or leased with usage restrictions.

Time burden calculation: the aggregate workload nobody wants to compute

This is the section of the feasibility assessment that separates sites that plan from sites that hope. The time burden calculation takes everything you have estimated -- coordinator hours, investigator time, nursing support, pharmacy touches, equipment scheduling -- and projects it across the entire study timeline. Not just "how much work is one visit." How much work is the entire study, from the first screening visit to the last close-out form, accumulated across all enrolled participants simultaneously.

And I will be direct: most sites skip this calculation. They assess resources per participant per visit, nod that the numbers seem manageable, and move on. What they fail to do is project forward to the point of peak enrollment, when the workload is not one participant's screening visit but 12 participants in various stages of the protocol, each with different visit schedules, some needing unscheduled safety visits, and the screening of new participants continuing in parallel.

Start with your enrollment projection from Lesson 1 of this module. If you expect to enroll two participants per month over a six-month enrollment window, your active participant count builds progressively. In Month 1, you have two active participants. In Month 3, you have six. In Month 6, you have 12 -- and all 12 are simultaneously active, each with their own visit schedule. For a 52-week treatment period, those 12 participants will remain active and requiring visits for months after enrollment closes.

Infrastructure gap analysis: what you have versus what you need

The four assessments above -- staff, space, equipment, and time -- produce a clear picture of what the study demands and what your site can provide. The gap analysis is where you compare the two and make an honest determination about whether the study is feasible.

Not every gap is a barrier. And not every sufficient resource means the study will run smoothly. The gap analysis requires classifying each finding into one of three categories.

Green: sufficient capacity. The site has the resource, it is available, and it can accommodate the study's requirements without displacing existing commitments. The coordinator has 15 available hours per week and the study requires 12 at peak. The site has a dedicated exam room with open scheduling. The pharmacy refrigerator has three shelves available. Green items require no action beyond documentation.

The site does not currently have the resource, or the resource is insufficient, but the gap can be closed through a defined action: purchasing additional equipment, hiring a part-time research nurse, contracting with a local imaging center for MRI access, or requesting a dedicated exam room block on the clinical schedule. Amber items are feasible, but they require time, coordination, and sometimes institutional approval. The feasibility assessment must identify both the gap and the proposed mitigation, including the timeline for resolution.

The output of the gap analysis is a document -- or a section of your feasibility assessment -- that summarizes the status of each resource domain, identifies any amber or red items, proposes mitigations for amber items with timelines, and flags red items for discussion with the investigator and sponsor. This document feeds directly into the feasibility questionnaire you will complete in Lesson 4 of this module.

One final observation, from years of watching this process. The sites that do the most rigorous resource evaluation are not the ones that decline the most studies. They are the ones that accept the right studies -- studies they can actually conduct well. And when problems arise during the study (as they inevitably do), these sites are better prepared, because they have already mapped their resource constraints and built contingencies around them. A thorough feasibility assessment is not pessimism. It is professionalism.

Key takeaways

Resource and infrastructure evaluation is the second pillar of feasibility -- and in many ways, the more operationally demanding one. Patients are either there or they are not. But resources exist on a spectrum: available, partially available, available with mitigation, and unavailable. The coordinator's job is to determine exactly where on that spectrum each resource falls.

Four principles to carry into your next feasibility assessment.

First, calculate staff time in aggregate, not per visit. The question is not whether a single visit is manageable. The question is whether the accumulated workload across all participants, all visit types, all studies, and all administrative tasks fits within your available hours -- especially during the peak enrollment period. If the peak week breaks the schedule, the study will break the coordinator.

Second, verify physical resources in person. Do not accept verbal assurances that "we have a freezer" or "the infusion room can accommodate another study." Open the freezer. Count the shelves. Walk into the infusion area and count the chairs. Space and equipment are physical realities, and physical realities are verified by observation, not assumption.