Researcher MCSR

Types of Research Required to Register

Massachusetts Controlled Substances Registration

The Details   of Researcher MCSR

What you need   for Researcher MCSR

Research projects involving an investigational new drug as defined in 21 CFR 312.3, or the investigational use of any drug in schedules I-VI where it will be administered or dispensed.  Each research project must be in possession of federally required approvals where applicable prior to applying for an MCSR.  These may include, an FDA Form 1572 and an IRB or IACUC letter of approval.

Who can apply:

The principal investigator of a research project, or the direct supervisor, department chair or chief academic officer of such person.

Can more than one research project be listed on a single application?

  • Yes, any and all projects that share a drug storage location can be listed on a single application. 

The following items will be the subject of an onsite inspection prior to the approval of any Researcher MCSR application.

Brief Project/Study Overview

Organizational Chart

Location Overview, including:

  • Floor Plan and Square Footage
  • General Hours of Operation
  • Visitor Policy (i.e.: access to building: escorted, non-escorted, etc.)
  • Other occupants, who are they?

Supplier Information:

  • Source of Research Drug
  • Name or person ordering
  • Process of Ordering
  • Process of Receiving/Deliveries
  • Process for Reverse Distribution/Destruction

Security Standard Operating Procedures and Policies

  • Access to the facility (individualized key cards, keys, etc.)
  • Access to limited areas/lab within facilities (Individualized key cards, keys, etc.)

Storage of controlled substances:

  • Safe/steel cabinet
  • Security of storage area (if applicable surveillance cameras, motion sensors, contact switches, glass break detectors, panic buttons, etc.)
  • Alarm Company Information
  • Who will be contacted if a breach occurs?

Recording Keeping:

  • How, where and for how long will the records be kept (bounded logbooks, electronic system, etc.)

Important information for Researchers

How to submit   Researcher MCSR


Health Professions Licensing Portal 

To create an account, navigate to and click the “CREATE ACCOUNT” button. 

Video tutorials with step-by-step instructions on creating an account are available online at:

If you need additional assistance, please contact us at 617-973-0949 or


The Bureau of Health Professions Licensure has moved to a new e-licensing platform.

To create an account, navigate to and click the “CREATE ACCOUNT” button.

PIN #:
If you have not received your PIN CODE please call us at 617-973-0949 and request one.

After linking your account to your registration, you may renew your MCSR online up to 90 days in advance of the registration expiration date.

Video tutorials with step-by-step instructions on creating/linking your account and renewing your registration are available online at:

If you need additional assistance, please contact us at 617-973-0949 or

Contact   for Researcher MCSR

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