MHRA PHASE I ACCREDITATION SCHEME: APPLICATION FORM
Please complete all relevant sections of this form, typed or in block capitals legibly using black
ink.
Electronic submission of forms to phase1accreditationscheme@mhra.gsi.gov.uk is preferable
where possible.
This should be completed in conjunction with the scheme requirements and guidance document.
Guidance notes (in Italics) are also provided for some sections. Responses should include references to
all relevant Standing Operating Procedures (SOPs).
Section 1: Administrative Data
Section 1.1 Applicant Details
(For companies with more than one unit located at different site where Phase I trials are conducted,
details for each facility to be covered by the Accreditation Scheme should be provided, along with a
description of the activities at each location. Differences in processes and site staff between sites
should be highlighted)
Organisation
name
Full address
Post Code
Contact name
Telephone no
Mobile
Email
Please highlight the activities performed at this site:
Additional Sites*
Organisation
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name
Full address
Post Code
Contact name
Telephone no
Fax
Mobile
Email
Please highlight the activities performed at this site:
Please highlight any differences in staff and processes between the sites:
*Add more additional site as necessary.
Section 1.2
MHRA Inspection History
Please provide a summary of the status of any corrective and preventive action
plans from previous MHRA GCP, GLP and Manufacturing/Importation
(Investigational Medicinal Product) inspections.
Please provide confirmation that there are no unresolved critical findings and no
unresolved major findings in the area of subject safety (e.g. eligibility, medical
cover, subject identification etc.) at the unit.
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Please list any significant changes in study processes, equipment & facilities,
workload, and key personnel since the last MHRA GCP and MIA (IMP)
Inspection. Company mergers and changes to structure of service provision
should be included.
Section 2: Unit Facilities & Procedures
These sections request details on procedures. If you have an existing procedure that
adequately addresses the question posed, please add this as an appendix, rather than
repeating the text here and refer to the appropriate procedure and appendix.
Section 2.1
Trial Design and set- up
Trial Design and Set- up
There must be procedures in place to ensure the unit receives all safety
information and can continuously assess and mitigate risk regarding all aspects
of the trial.
Describe the process in place to ensure contracts & agreements with sponsors
(or internal MOU for in-house units) include procedures and responsibilities for
notifying the investigator immediately if/when new safety/toxicology data comes
to light.
Describe the process in place for risk assessment and risk
management/mitigation strategy to demonstrate verification and continuous
assessment of all aspects of a trial.
Describe the process in place for dose escalation /safety reviews.
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Section 2.2
Medical Emergencies and Facilities
Hospital Agreements
It is expected that the unit has either an existing formal agreement with a local
hospital for supporting emergencies arising from clinical trials conducted within
the unit and/or is able to demonstrate communication and notification of trial
information (e.g. dosing times) with the hospital emergency teams.
Does the unit have an existing formal agreement with a local hospital for
supporting emergencies arising from clinical trials?
YES
NO
If YES, please append the agreement.
If NO, please describe the communication and notification procedures in place
to demonstrate how hospital emergency response teams are aware of the unit
and nature of research undertaken.
Have hospital emergency teams or ICU teams visited the unit?
YES
NO
If yes, under what circumstances? (e.g. an emergency, as part of a test, a
meeting etc.)
How far away is the nearest hospital with ICU facilities? What is the estimated
travelling time taking peak time travel into consideration? i.e. how long is it likely
to take to transfer a subject to hospital taking into account the worst traffic
scenario?
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Has the unit tested the transfer to hospital? What evidence is available to
support the testing?
Emergency Equipment and Facilities
An emergency trolley should be available that is easily and rapidly accessible.
There should be a trolley in each main ward area, and which can be moved
quickly to where it is needed. The emergency trolley should be stocked as per
the current UK Resuscitation Council (UK) guidelines
Supply a floor plan of the clinical areas of the unit with the location of the
following marked:
 Emergency trolley(s)
 Areas where the subjects will be (e.g. showers, toilets, ward areas) and
indicate the location of alarm points.
Describe what items of equipment/apparatus are stocked on the emergency
trolley as a minimum.
Describe the frequency and method of checking the contents of the emergency
trolley, including how such checks are documented.
Detail what continuous monitoring equipment is available within the unit (e.g.
ECG, pulse oximetry, vital signs measurements etc.)
Do beds (if used for dosing days) tilt and adjust for height?
YES
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Describe the alarm mechanism (i.e. the alarms points identified in the plan) and
how the alarms are tested.
Describe how bathroom doors can be opened from the outside in the event of
an emergency.
Description of Medical Emergency Procedures
The unit must have robust (and tested) written procedures for the management
of medical emergencies.
Describe what procedures are in place for handling common medical
emergencies (e.g. such as syncope, hypotension, anaphylaxis, cardiac arrest)
and stabilising subjects in an acute emergency.
Describe the procedure for transfer of subjects to hospital.
Describe the procedure and testing for out-of-hours medical cover, including
contact with the sponsor or IMP responsible person(s).
Describe the procedure and testing for unblinding in the event of an emergency
for blinded trials.
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Section 2.3
Staff: Training and Experience
The unit must have sufficient numbers of appropriately trained staff for handling
medical emergencies should they arise. Please provide a current organogram
for medical and clinical staff. All staff must be tested (and documented)
periodically with the use of emergency scenarios within the unit. For those staff
in contact with subjects, they must attend at least one scenario a year.
The unit should be able to demonstrate it has sufficient numbers of trained and
experienced staff to undertake the trials they are conducting and the activities
allocated to staff and also that there is adequate resource allocated.
What documentation is available to demonstrate that medical doctors are
authorised to act as Principal Investigator, including first in human trials?
Describe the minimum staffing levels in place during the clinical conduct of a
study. How is sufficient cover by trained staff ensured on dosing days and
overnight stays?
Describe the procedures in place for training and refresher training in
emergency resuscitation procedures. Does this apply equally to contract and
agency staff?
Describe the procedures in place to ensure staff are appropriately and currently
trained to initiate resuscitation, i.e. basic airway management and ventilation,
i.v. cannulation and fluid therapy, giving adrenaline, CPR and use of automated
external defribrillator (AED)
What emergency situations have the unit managed in the last 2 years, i.e. what
on the job training / experience can be demonstrated?
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How often do rehearsals of emergency procedures take place and what records
are retained? Who is involved?
Section 2.4
Subject Identification and Verification
The unit must be able to ensure they can address aspect related to the
identification and verification of the subject, including aspects that facilitate
verification of the subjects volunteering and medical history.
Describe the procedure in place to address ‘over-volunteering.’
Describe the procedure in place for the accurate identification of subjects to
verify their existence and also to ensure that the person screened is the person
dosed.
For FIH and EAG type trials describe the procedure for ensuring a subjects’
past medical history is received via the subjects’ GP (for volunteers), or other
medic such as a hospital consultant (e.g. for patient trials where there are no
medical records available). How does the unit provide assurance that the
inclusion and exclusion criteria are met?
Describe what 24-hour emergency contact details are provided to subjects for
use while they are outside the unit.
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Section 2.5
Description of Quality System
The unit must have written procedures for every aspect of the study process.
Please provide a description of the quality system and a current list of
SOP/Procedures.
Describe how the effectiveness of study process procedures is assessed, i.e.
how do you ensure that the unit complies with its own procedures, and how do
you assess whether those procedures are adequate?
How often are internal audits conducted?
Section 3: Requirement for EAG type trials
Description of Procedures for managing serious medical emergencies
Documentation that demonstrates that appropriately trained and experienced
staff are available on dosing days. During the conduct of EAG type trials,
medical doctors trained to Advanced Life Support (ALS)A standards and
experienced in handling medical emergencies must be present during and
following dosing for a defined period. In addition to theoretical knowledge, the
medical doctors must have relevant and recent experience of handling medical
emergencies. Units may approach this in a number of ways, for example:

The units employed (or core staff) Clinical Research Physicians (CRP)
are ALS trained A and may participate on an ongoing basis in periodic
clinical attachments involving participation in a hospital resuscitation
team rota to ensure continued exposure to identifying and handling real
medical emergencies B.

Appropriately trained clinicians with up-to-date emergency medicine
experience may be brought in to the unit on a contract basis during
dosing days. These contract staff must also be trained in ALS, the study
protocol, unit procedures and GCP. The contractor would not be
expected to take on the role of the Principal Investigator and must be
appropriately supervised whilst in the unit. Indemnity arrangements
made by the Sponsor and/or unit must also apply to the contract medic.

Phase I unit may be located within a hospital; with critical care facilities.
Or
Or
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The unit will have 24-hour access to the hospital emergency response
team, who can arrive at the unit within minutes of an emergency.
A For
paediatric Phase I trials an equivalent paediatric life support training (for example, Advanced
Paediatric Life Support (APLS) or European Paediatric Life Support (EPLS).
B Where the unit uses its employed (or core) CRPs to provide cover in a medical emergency, the
CRPs must be able to demonstrate appropriate training and experience in handing medical
emergencies. A procedure must be in place to address the assessment of continuing competency
in this area (e.g. it may be achieved by peer review, audit or other means). This continuing
assessment must be documented and countersigned by the assessors. Evidence must be kept to
document exposure to medical emergencies in order to demonstrate that they remain
experienced and competent to handle such emergencies.
Describe how the unit ensures appropriately trained and experienced staff are
available on dosing days
How does the unit ensure that their medical doctors have both practical
experience and theoretical knowledge in handling medical emergencies?
How does the unit assess their medical doctors for continuing competency of
hand on experience in medical emergencies?
Section 4: Key Personnel
1. Please complete a separate Section 3 form for each key member of staff, for example, Medical
Director, Unit Manager , PIs for FIH trials, Senior Nurse, Pharmacist/QPs, person responsible for
Quality System/SOPs etc.
2. Each nomination must be signed by both the nominee and the applicant.
3. Each nomination must include a relevant CV and a copy of the nominee’s job description.
Name
Job Title
Full address
106739377
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Post Code
Employment
Status (full-time,
part-time,
Consultant)
Telephone no
Fax
Mobile
Email
Qualifications (relevant to this application)
Please include any Life Support training e.g. Basic, Immediate, Advanced
Experience (brief details of employment and responsibilities relevant to this
application)
Professional Association(s)
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I confirm that the above particulars are accurate and true to the best of my knowledge and belief. I agree to be
nominated as a Principal Investigator/Key Member of Staff
Signed (Nominee):
Date:
Print Name:
Signed (Applicant):
Date:
Print Name:
Section 5: DECLARATION
To the best of my knowledge and belief the particulars I have given in this form are correct, truthful
and complete.
I confirm that significant changes to the content of this application will be notified to MHRA,
electronically to phase1accreditationscheme@mhra.gsi.gov.uk. Significant changes are those that
affect the basis upon which the accreditation was based for example:




Relocation of the unit, or addition/change to facilities (e.g. extension of existing unit, the
permanent use of facilities at another location).
Significant changes to procedures that impact on key aspects of the accreditation scheme
(e.g. changes to procedures relating to medical emergencies, subject recruitment, resourcing
and staffing, minimum staffing requirements, risk assessment etc.)
Changes in key personnel – titles used for key personnel will differ between organisations and
units will need to review the requirements in the accreditation scheme and determine which
personnel are key to attaining and maintaining those requirements. However, in general,
these will be the medical doctors, including the Medical Director (or medical doctor who has
overall responsibility for medical aspects), any PI’s authorised for FIH trials (or the person
responsible for assessing the PI for a clinical trial), Senior Nurses, Clinic Manager (i.e. the
person who has overall responsibility for the day to day running of the clinic and the clinic
equipment, e.g. emergency trolley), the Pharmacist or individual responsible for the
emergency drugs and also the person responsible for maintaining the units quality system
Significant contractual changes in agreements with local hospitals.
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A list of those units that have received accreditation, and the type of accreditation received,
will be published on the MHRA website. Please tick this box if you do not wish your
organisation to be listed on the website :

Signed:
Date:
Name:
(BLOCK CAPITALS)
Position:
Signed:
Date:
Name:
(BLOCK CAPITALS)
Position:
(see note below *)
(see note below *)
* Signatories should include the Unit Manager and the CEO
When complete please return the form, plus any supporting documents electronically to
phase1accreditationscheme@mhra.gsi.gov.uk
Alternatively a hard copy can be mailed to:
GCP Inspectorate
MHRA
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
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