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.

A screening visit for a complex study might require 30 minutes of pre-visit preparation (pulling charts, confirming eligibility questions, preparing consent documents), 60 to 90 minutes of participant contact (consent discussion, medical history, vital signs, specimen collection), and 45 to 60 minutes of post-visit work (data entry, specimen processing and shipping, query resolution, scheduling the next visit). That is 2.5 to 3 hours of coordinator time for a single screening visit. Multiply by the number of participants you plan to screen -- remembering that screening failures consume coordinator time without producing an enrolled participant.

Treatment visits may be shorter or longer depending on the protocol. An infusion visit with pharmacokinetic sampling might require the coordinator's intermittent attention over four to six hours. A simple follow-up visit with vitals and questionnaires might take 45 minutes total. The key is to estimate the time for each visit type and then aggregate across the enrollment plan.

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?

Nursing support. 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.

Pharmacy support. If the study involves investigational product dispensing, preparation, or reconstitution, the research pharmacist or pharmacy technician becomes a critical resource. Pharmacy time requirements include receiving and inventorying IP shipments, verifying storage conditions, preparing doses (particularly for blinded studies requiring over-encapsulation or reconstitution), dispensing to participants, maintaining accountability logs, and managing returns or destruction. For studies with complex IP handling, pharmacy time can be substantial.

Administrative coverage. This is the category most sites skip entirely during feasibility. But someone answers the phone when participants call between visits. Someone schedules appointments. Someone processes the invoices to the sponsor. Someone files the monitoring visit reports. If your site has a research administrator or front-desk staff dedicated to research, account for their bandwidth. If those functions fall to the coordinator, add them to your coordinator time estimate.

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.

For the feasibility assessment, you need to determine not just whether space exists, but whether it is available at the times and frequency the protocol demands.

Examination rooms. How many study visits per week will you need to conduct at peak enrollment? If you expect 12 active participants with bi-weekly visits, that is approximately six visits per week. If each visit requires 90 minutes of exam room time, you need nine hours of exam room availability per week. Do you have it? If the room is shared, are there scheduling blocks reserved for research, or are you fitting visits around clinical appointments?

Infusion capacity. For studies requiring infusions, this is often the bottleneck. Count the number of infusion chairs or beds available for research use. Determine the infusion duration per the protocol, including pre-infusion assessments, the infusion itself, and any post-infusion observation period. Then calculate the throughput: how many participants can you infuse per day, given the hours of operation and the turnaround time between participants? If the protocol requires a four-hour infusion with one hour of post-infusion observation, each chair can accommodate one participant per day (assuming a standard eight-hour operation). Three chairs means three infusions per day. If peak enrollment requires six infusions per week, you need two infusion days per week at minimum.

Specimen processing areas. Pharmacokinetic studies and biomarker studies frequently require timed specimen processing -- centrifugation within 30 minutes of collection, aliquoting into cryovials, and immediate freezing. This work requires bench space, a centrifuge, pipettes, and a freezer within close proximity. If your site does not have a dedicated specimen processing area, you need to identify where this work will occur and whether it can be done within the protocol's specified processing windows.

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."

Step 2: Verify availability. 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.

Step 3: Check calibration and maintenance. Regulatory requirements and protocol specifications typically mandate that equipment used in clinical trials be calibrated and maintained according to the manufacturer's schedule and documented accordingly. Per ICH E6(R3), Section 3.11.4.5.2(a), the sponsor should confirm that the investigator has adequate qualifications, resources (see sections 2.1, 2.2, and 3.7) and facilities, including laboratories, equipment, and investigator site staff, to conduct the trial safely and properly. During monitoring visits, the monitor will ask for calibration records. If the site's spirometer has not been calibrated in 18 months, that is a problem you want to discover during feasibility, not during the site initiation visit.

For each device, determine: When was it last calibrated? Is the calibration current per the manufacturer's recommended schedule? Is there a documented maintenance log? Is there a service contract, or does the institution handle maintenance internally? If calibration is overdue or maintenance has lapsed, factor the time and cost of remediation into your feasibility assessment.

Step 4: Assess capacity. A single ECG machine shared among three active studies and the clinical cardiology practice may not have the throughput for a fourth study that requires ECGs at every visit. Capacity constraints are particularly acute for high-demand equipment: infusion pumps, centrifuges, specialized imaging devices, and ultra-low-temperature freezers. If the existing equipment is at or near capacity, adding a new study without adding equipment will create scheduling conflicts and delays.

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.

The enrollment accumulation curve. 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.

The workload peaks not at the start of the study but months into it, when maximum enrollment has been reached and all participants are in the treatment phase simultaneously. This is the point at which your resources are most strained, and this is the point your feasibility assessment must evaluate.

Factoring in screening failures. Here is a detail that catches sites by surprise. Screening failures consume resources. A participant who consents, undergoes the screening visit, fails a laboratory criterion, and is discontinued has still consumed coordinator time, investigator time, exam room time, and laboratory resources. That work is not recovered. If your expected screen failure rate is 30%, and you need to enroll 12 participants, you should plan to screen approximately 17. Those five additional screening visits are real workload that must be accounted for.

Visit windows and scheduling flexibility. Most protocols define visit windows -- a plus-or-minus range around the target visit date. A bi-weekly visit with a plus-or-minus three-day window means each visit must occur within a seven-day span. Tight windows reduce scheduling flexibility and increase the likelihood that visits will cluster. If four participants are all due for their bi-weekly visit within the same week, the coordinator must accommodate four visits in that window, regardless of what else is scheduled. Loose windows (plus-or-minus seven days or more) provide more scheduling flexibility and reduce peak clustering.

When calculating the time burden, consider the window constraints. Tighter windows mean less ability to spread visits evenly across the week. More clustering means higher peak daily and weekly workloads.

Unscheduled visits. Every protocol includes provisions for unscheduled visits -- typically for adverse event assessment, dose-modification evaluations, or early termination procedures. Unscheduled visits are, by definition, unpredictable. But they are not zero. A reasonable planning assumption, based on my experience across therapeutic areas, is that unscheduled visits add 10% to 20% to the total scheduled visit volume over the life of the study. For a study with 15 scheduled visits per participant and 12 enrolled participants, that is 180 scheduled visits plus 18 to 36 unscheduled visits. The unscheduled visits tend to concentrate during periods of dose escalation or when participants are experiencing new symptoms -- precisely when the coordinator's workload is already elevated.

Close-out activities. The study does not end when the last participant completes the last visit. Close-out activities include final data entry and query resolution, source document verification preparation, investigational product reconciliation and return, regulatory binder completion, essential document filing, archiving, and the close-out monitoring visit. Close-out can consume four to eight weeks of intermittent but substantial coordinator time, depending on study complexity and the volume of outstanding queries. If you are already planning to start a new study as the current one winds down, the close-out workload from the ending study overlaps with the start-up workload for the new one.

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.

Amber: gap with available mitigation. 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.

Red: critical gap without clear resolution. The site lacks a resource that is essential for study conduct, and there is no practical path to acquiring it within the start-up timeline. The protocol requires minus 80-degree Celsius freezer storage and the site has no ultra-low freezer and no budget to purchase one. The investigator is available only four hours per week and the study requires 10 hours of investigator time at peak enrollment. The site has no infusion capability and the study requires intravenous dosing. Red items are potential study-stoppers. They must be communicated to the investigator and the sponsor transparently.

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.

Third, classify gaps honestly. Green, amber, or red -- each classification requires a different response. Amber gaps are not failures. They are opportunities to demonstrate operational competence by identifying the gap, proposing the mitigation, and providing a realistic timeline. Red gaps are not shameful. They are honest limitations that, if disclosed, protect both the site and the participants.

Fourth, project forward to peak workload. The study does not operate at its average intensity. It operates at its peak intensity for weeks or months at a time. Your feasibility assessment must evaluate resources at peak, not average. A site that is comfortable at Month 2 but drowning at Month 8 made an assessment error at Month 0.

In the next lesson, we turn to the third dimension of feasibility: competing studies and therapeutic area saturation -- the question of whether your site has room for this study in the context of everything else it is already doing.

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.

A screening visit for a complex study might require 30 minutes of pre-visit preparation (pulling charts, confirming eligibility questions, preparing consent documents), 60 to 90 minutes of participant contact (consent discussion, medical history, vital signs, specimen collection), and 45 to 60 minutes of post-visit work (data entry, specimen processing and shipping, query resolution, scheduling the next visit). That is 2.5 to 3 hours of coordinator time for a single screening visit. Multiply by the number of participants you plan to screen -- remembering that screening failures consume coordinator time without producing an enrolled participant.

Treatment visits may be shorter or longer depending on the protocol. An infusion visit with pharmacokinetic sampling might require the coordinator's intermittent attention over four to six hours. A simple follow-up visit with vitals and questionnaires might take 45 minutes total. The key is to estimate the time for each visit type and then aggregate across the enrollment plan.

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?

Nursing support. 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.

Pharmacy support. If the study involves investigational product dispensing, preparation, or reconstitution, the research pharmacist or pharmacy technician becomes a critical resource. Pharmacy time requirements include receiving and inventorying IP shipments, verifying storage conditions, preparing doses (particularly for blinded studies requiring over-encapsulation or reconstitution), dispensing to participants, maintaining accountability logs, and managing returns or destruction. For studies with complex IP handling, pharmacy time can be substantial.

Administrative coverage. This is the category most sites skip entirely during feasibility. But someone answers the phone when participants call between visits. Someone schedules appointments. Someone processes the invoices to the sponsor. Someone files the monitoring visit reports. If your site has a research administrator or front-desk staff dedicated to research, account for their bandwidth. If those functions fall to the coordinator, add them to your coordinator time estimate.

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.

For the feasibility assessment, you need to determine not just whether space exists, but whether it is available at the times and frequency the protocol demands.

Examination rooms. How many study visits per week will you need to conduct at peak enrollment? If you expect 12 active participants with bi-weekly visits, that is approximately six visits per week. If each visit requires 90 minutes of exam room time, you need nine hours of exam room availability per week. Do you have it? If the room is shared, are there scheduling blocks reserved for research, or are you fitting visits around clinical appointments?

Infusion capacity. For studies requiring infusions, this is often the bottleneck. Count the number of infusion chairs or beds available for research use. Determine the infusion duration per the protocol, including pre-infusion assessments, the infusion itself, and any post-infusion observation period. Then calculate the throughput: how many participants can you infuse per day, given the hours of operation and the turnaround time between participants? If the protocol requires a four-hour infusion with one hour of post-infusion observation, each chair can accommodate one participant per day (assuming a standard eight-hour operation). Three chairs means three infusions per day. If peak enrollment requires six infusions per week, you need two infusion days per week at minimum.

Specimen processing areas. Pharmacokinetic studies and biomarker studies frequently require timed specimen processing -- centrifugation within 30 minutes of collection, aliquoting into cryovials, and immediate freezing. This work requires bench space, a centrifuge, pipettes, and a freezer within close proximity. If your site does not have a dedicated specimen processing area, you need to identify where this work will occur and whether it can be done within the protocol's specified processing windows.

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."

Step 2: Verify availability. 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.

Step 3: Check calibration and maintenance. Regulatory requirements and protocol specifications typically mandate that equipment used in clinical trials be calibrated and maintained according to the manufacturer's schedule and documented accordingly. Per ICH E6(R3), Section 3.11.4.5.2(a), the sponsor should confirm that the investigator has adequate qualifications, resources (see sections 2.1, 2.2, and 3.7) and facilities, including laboratories, equipment, and investigator site staff, to conduct the trial safely and properly. During monitoring visits, the monitor will ask for calibration records. If the site's spirometer has not been calibrated in 18 months, that is a problem you want to discover during feasibility, not during the site initiation visit.

For each device, determine: When was it last calibrated? Is the calibration current per the manufacturer's recommended schedule? Is there a documented maintenance log? Is there a service contract, or does the institution handle maintenance internally? If calibration is overdue or maintenance has lapsed, factor the time and cost of remediation into your feasibility assessment.

Step 4: Assess capacity. A single ECG machine shared among three active studies and the clinical cardiology practice may not have the throughput for a fourth study that requires ECGs at every visit. Capacity constraints are particularly acute for high-demand equipment: infusion pumps, centrifuges, specialized imaging devices, and ultra-low-temperature freezers. If the existing equipment is at or near capacity, adding a new study without adding equipment will create scheduling conflicts and delays.

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.

The enrollment accumulation curve. 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.

The workload peaks not at the start of the study but months into it, when maximum enrollment has been reached and all participants are in the treatment phase simultaneously. This is the point at which your resources are most strained, and this is the point your feasibility assessment must evaluate.

Factoring in screening failures. Here is a detail that catches sites by surprise. Screening failures consume resources. A participant who consents, undergoes the screening visit, fails a laboratory criterion, and is discontinued has still consumed coordinator time, investigator time, exam room time, and laboratory resources. That work is not recovered. If your expected screen failure rate is 30%, and you need to enroll 12 participants, you should plan to screen approximately 17. Those five additional screening visits are real workload that must be accounted for.

Visit windows and scheduling flexibility. Most protocols define visit windows -- a plus-or-minus range around the target visit date. A bi-weekly visit with a plus-or-minus three-day window means each visit must occur within a seven-day span. Tight windows reduce scheduling flexibility and increase the likelihood that visits will cluster. If four participants are all due for their bi-weekly visit within the same week, the coordinator must accommodate four visits in that window, regardless of what else is scheduled. Loose windows (plus-or-minus seven days or more) provide more scheduling flexibility and reduce peak clustering.

When calculating the time burden, consider the window constraints. Tighter windows mean less ability to spread visits evenly across the week. More clustering means higher peak daily and weekly workloads.

Unscheduled visits. Every protocol includes provisions for unscheduled visits -- typically for adverse event assessment, dose-modification evaluations, or early termination procedures. Unscheduled visits are, by definition, unpredictable. But they are not zero. A reasonable planning assumption, based on my experience across therapeutic areas, is that unscheduled visits add 10% to 20% to the total scheduled visit volume over the life of the study. For a study with 15 scheduled visits per participant and 12 enrolled participants, that is 180 scheduled visits plus 18 to 36 unscheduled visits. The unscheduled visits tend to concentrate during periods of dose escalation or when participants are experiencing new symptoms -- precisely when the coordinator's workload is already elevated.

Close-out activities. The study does not end when the last participant completes the last visit. Close-out activities include final data entry and query resolution, source document verification preparation, investigational product reconciliation and return, regulatory binder completion, essential document filing, archiving, and the close-out monitoring visit. Close-out can consume four to eight weeks of intermittent but substantial coordinator time, depending on study complexity and the volume of outstanding queries. If you are already planning to start a new study as the current one winds down, the close-out workload from the ending study overlaps with the start-up workload for the new one.

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.

Amber: gap with available mitigation. 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.

Red: critical gap without clear resolution. The site lacks a resource that is essential for study conduct, and there is no practical path to acquiring it within the start-up timeline. The protocol requires minus 80-degree Celsius freezer storage and the site has no ultra-low freezer and no budget to purchase one. The investigator is available only four hours per week and the study requires 10 hours of investigator time at peak enrollment. The site has no infusion capability and the study requires intravenous dosing. Red items are potential study-stoppers. They must be communicated to the investigator and the sponsor transparently.

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.

Third, classify gaps honestly. Green, amber, or red -- each classification requires a different response. Amber gaps are not failures. They are opportunities to demonstrate operational competence by identifying the gap, proposing the mitigation, and providing a realistic timeline. Red gaps are not shameful. They are honest limitations that, if disclosed, protect both the site and the participants.

Fourth, project forward to peak workload. The study does not operate at its average intensity. It operates at its peak intensity for weeks or months at a time. Your feasibility assessment must evaluate resources at peak, not average. A site that is comfortable at Month 2 but drowning at Month 8 made an assessment error at Month 0.

In the next lesson, we turn to the third dimension of feasibility: competing studies and therapeutic area saturation -- the question of whether your site has room for this study in the context of everything else it is already doing.