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 tois 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 1.1Applicant 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 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.
Please list any significant changes in study processes, equipment & facilities, workload, and key personnelsince 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 2.1Trial 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.

Section 2.2Medical 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?
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 NO
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.

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?
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 historyis 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.

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.
Or
  • 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.
Or
  • Phase I unit may be located within a hospital; with critical care facilities. 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 theirmedical 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
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)

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. 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 drugsand also the person responsible for maintaining the units quality system
  • Significant contractual changes in agreements with local hospitals.

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: / Position:
(BLOCK CAPITALS) / (see note below *)
Signed: / Date:
Name: / Position:
(BLOCK CAPITALS) / (see note below *)

* Signatories should include theUnit Manager and the CEO

When complete please return the form, plus any supporting documents electronically to

Alternatively a hard copy can be mailed to:

GCP Inspectorate

MHRA

151 Buckingham Palace Road

Victoria

London

SW1W 9SZ

MHRA Phase 1 Accreditation Application Form (Organisation Name) (Status and Date) Version 31Oct131(13)