The proposal came in as an email attachment three weeks ago. Legal's approval is a comment in the margin of a Word file that has been renamed twice since. Someone asked this morning which investigator studies are behind on enrollment, and the honest answer is that nobody can say without opening six inboxes.
How medical affairs runs an investigator-initiated study comes down to three things, none of which involve running the trial: a defined intake, a decision a reviewer can find a year later, and milestones that keep the study visible after the contract is signed. Investigator-initiated studies (IIS) are unsolicited. The investigator proposes the research and serves as its sponsor, and the company decides only whether to support it.
The short answer
Medical affairs sets the evidence question before proposals arrive, takes them in through a short application and then a full protocol, records the approve-or-reject decision with a name and a reason, and tracks payment milestones through to the manuscript. The investigator stays the sponsor throughout. The company supports the study; it does not conduct it.
This is the distinction everything else rests on, and it is the one most often blurred in internal conversation.
The Medical Affairs Professional Society defines investigator-initiated research as unsolicited, independent research in which the investigator or the institution — academic, private, or governmental — serves as the sponsor, with a pharmaceutical or medical device company providing support as study drug, device, funding, or some combination. Unsolicited is the operative word. The idea originates outside the company.
Under 21 CFR 312.3, a sponsor-investigator is the individual who both initiates and conducts the investigation. That single sentence carries the whole allocation of duty: protocol, conduct, and regulatory obligations sit with the investigator, not with the company writing the check.
The vocabulary varies by whoever is in the room. MAPS uses investigator-initiated research (IIR). The Association of Clinical Research Professionals writes about investigator-initiated sponsored research (IISR), meaning the same arrangement seen from the grant-support side. Investigator-initiated trial is a common synonym. The terms describe one thing, and a medical affairs team is well served by picking one and using it consistently in its own documents.
Supporting a study you do not run is a narrower job than it first appears, and a more administrative one.
The company owes the investigator a decision, a contract, the agreed support, and oversight of its own obligations. It does not owe them a protocol, a monitoring plan, or case-report forms. Where teams get into difficulty is the space between those two lists: a medical director offers to "help tighten the endpoints," and the line between supporting research and directing it starts to move.
The operating load breaks into four pieces. Deciding what you are willing to support. Taking proposals in without losing them. Recording why each one was approved or turned down. Knowing, at any point afterwards, which studies are on schedule and which are not. A program that handles three of those and not the fourth is the program that cannot answer the enrollment question.
MAPS is direct about sequencing: the strategy belongs in the medical plan, written before proposals start arriving rather than assembled in response to them.
In practice that means publishing areas of interest. MAPS describes a choice between detailed areas of interest, which produce fewer and more focused proposals, and broad ones, which produce more proposals and more room to choose. Neither is wrong. A team with a small budget and a specific gap wants the detailed version; a team early in a program and still mapping the evidence gaps usually wants the broad one.
The strategy also has to say what you will not fund. MAPS flags limiting overlap with company-sponsored studies, and specifically patient overlap — two studies competing for the same patients at the same sites is a problem you create at the strategy stage and discover at the enrollment stage. Any single investigator study is one chapter of a wider evidence plan, and deciding where it sits in that plan is cheaper before the proposal arrives than after.
Two submission styles are in common use, and the choice shapes everything downstream.
Window submissions open once or twice a year. A cross-functional committee reviews every proposal together against a set budget, which makes comparison straightforward and duplication easy to spot. The cost is waiting: a strong proposal that lands the week after a window closes sits until the next one.
Rolling submissions accept proposals throughout the year. MAPS describes a two-stage shape for this. A brief application gets a decision within 45 days of submission — a yes or no on whether the company is interested, with no funding decision attached. Full applications then go to quarterly review meetings where funding is decided, with medical affairs reviewing and other functions giving input as needed.
The two-stage split is the part worth copying even if you run windows. It costs an investigator very little to find out early that the company has no interest in their question, and it saves them writing a full protocol for a study that was never going to be funded.
ACRP describes a standing review group drawing on medical affairs, legal, compliance, R&D, regulatory, and commercial — not every function on every proposal, but a defined group rather than whoever is free that week.
Their stronger point concerns what survives the meeting. ACRP calls for a written procedure and a record of each proposal that was received. A decision that lives only in a thread is, for practical purposes, a decision that did not happen.
What has to persist is modest. The proposal as submitted. Who reviewed it. The outcome. The reason. A date. Reconstructing those five fields from memory eighteen months later is the work this section exists to prevent.
The decision, the reviewer's name, and the reason have to live on the study itself — not in a Word comment that disappears with the next version of the file.
Approval is the point at which most programs stop paying attention, which is why the enrollment question is so hard to answer.
MAPS ties payment to the aims set out in the protocol, which is the reason a detailed budget and protocol matter at contracting rather than afterwards. The pattern it describes is four milestone payments: contract execution, including non-refundable costs such as IRB submission and site and pharmacy start-up; 50% enrollment; 100% enrollment, or last patient enrolled; and submission of the manuscript or final study report, which carries the last 10–15% of the total budget. Larger studies get broken into smaller milestones.
Holding the final tranche against the manuscript is doing specific work. The company's interest in an investigator-initiated study is the published evidence, and a completed study that never reaches a journal has not delivered the thing that justified supporting it.
| Step | Who owns it | Done when |
|---|---|---|
| Strategy and areas of interest | Medical affairs, inside the medical plan | Published before the submission window opens |
| Short application | Investigator submits; medical affairs screens | Rolling submissions: interest confirmed or declined within 45 days, no funding decision (MAPS) |
| Full review | Standing committee: medical affairs, legal, compliance, and others as needed | Approve or reject recorded with reviewer and reason |
| Contract and first payment | Legal, with medical affairs on scope | Contract executed; IRB and start-up costs released (MAPS: payment 1 of 4) |
| Enrollment milestones | Investigator reports; medical affairs tracks | 50% enrolled, then 100% or last patient enrolled (MAPS: payments 2 and 3) |
| Manuscript and close | Investigator authors; medical affairs closes the record | Manuscript or final report submitted; final 10–15% released (MAPS: payment 4) |
The 45-day screen, the four payments, and the 10–15% final tranche are the practice described by MAPS, not a regulatory requirement. Budgets and timelines are set per study.
The local relationship is where most investigator studies actually begin.
MAPS treats the field connection as central, and makes a point about the people on the other side that program design tends to forget: most investigators are practicing clinicians who also do research, and they have little patience for administration. An intake process that assumes otherwise will quietly lose good proposals to the effort required to submit them.
MAPS also describes areas-of-interest documents being used to prepare field medical staff for unsolicited discussion with KOLs and external investigators. That often happens well before there is a formal program to receive the idea — the same dynamic as field medical work in the pre-launch period, where the conversations run ahead of the structure built to support them. ACRP notes that field staff often visit the sponsor-investigator after approval as well, so the relationship runs the length of the study.
What the MSL does not own is equally firm. Not the funding decision, which belongs to the committee. Not the contract. Not the protocol, which belongs to the sponsor-investigator. An MSL who starts shaping protocol content has moved the company across the line that makes the study investigator-initiated in the first place.
Most of this can be run on a shared drive and a spreadsheet, and plenty of teams do. What breaks first is usually the decision record and the post-contract view. TikaEvidence and Studies is built around those two points: three books — investigator studies, company-sponsored non-interventional and real-world evidence, and research collaborations — with unused books turned off. The protocol stays a Word file and is reviewed in Word Online. Approve or reject is stored on the study with the reviewer's name and the reason, and after the final approval that customer has configured, the Word file is frozen. Milestones, spend, and the principal investigator — the same HCP record the field team already works from — sit on the study, and a ClinicalTrials.gov identifier can be stored alongside them. It is an opt-in module, and it can sit inside TikaMSL or beside a CRM the company already runs.
IIS stands for investigator-initiated study. In the plural, investigator-initiated studies (IIS) are research proposed and led by an external physician or institution, with a pharmaceutical or medical device company providing support such as study drug, device, or funding. The same arrangement is also written as IIR (investigator-initiated research), IISR (investigator-initiated sponsored research), or investigator-initiated trial.
The investigator or their institution is the sponsor, not the company providing support. MAPS defines investigator-initiated research as unsolicited, independent research where the investigator or institution serves as sponsor. Under 21 CFR 312.3, a sponsor-investigator is the individual who both initiates and conducts the investigation.
Medical affairs defines the areas of interest before proposals arrive, runs intake and review, records the decision, and tracks milestones and spend through to the manuscript. It does not write the protocol or conduct the study. The practical test is whether the team can say, on any given day, which supported studies are behind schedule.
Proposals are assessed against published areas of interest by a standing cross-functional group. ACRP describes that group drawing on medical affairs, legal, compliance, R&D, regulatory, and commercial. MAPS describes a two-stage route under rolling submissions: a brief application answered within 45 days on interest alone, then a full application reviewed quarterly for funding.
Payments follow the aims set out in the protocol. MAPS describes a common pattern of four milestone payments: contract execution including IRB and start-up costs, 50% enrollment, 100% enrollment or last patient enrolled, and submission of the manuscript or final report, which carries the last 10–15% of the budget. Larger studies are often split into smaller milestones.
No. Oversight means tracking the decision, the contract, the milestones, the spend, and the outcome of a study someone else is conducting. Running a trial means capturing case-report data, monitoring sites, and preparing regulatory submissions, all of which sit with the sponsor-investigator. The two need different systems and different people.
Sources
See one investigator-initiated study end to end — intake, the recorded decision, milestones, and spend — in twenty minutes.