Integrated Research Application System (IRAS)

Transcription

1 Integrated Research Application System (IRAS) Collated guidance on MHRA Devices Forms Content FORM PCA1 Part 1: About the notification 1. Date of submission to the Competent Authority 2. First submission to MHRA or re submission? 3. Multi country investigations 4. Manufacturer's statement Part 2: Manufacturer Information 5. Manufacturer 6. Manufacturer's authorised representative Part 3: Device Information 7. Manufacturer's trade name 8. Notified Body approval of quality system or process 10. Generic name 11. Class of device Part 4: Clinical Trial Information 12. Number of devices in the trial 14. Trial monitor 15. UK contact point 16. Fee payable to the Competent Authority 17. Application to Research Ethics Committee Part 5: Clinical Investigators and trial sites 19. Single site or multi site trial? 20. Principal Clinical Investigator 21. Additional Clinical Investigators FORM PCA2 STERILISATION ANNEXES Integrated Research Application System (IRAS) 1

2 FORM PCA1 Part 1: About the notification 1. Date of submission to the Competent Authority This should be completed immediately prior to submission. 2. First submission to MHRA or re submission? Re submission should only be selected in cases where a manufacturer is re submitting an application which has previously been objected to by MHRA. If this is the case, please provide the MHRA reference number for the previous submission to which MHRA objected. 3. Multi country investigations If this is part of a multi country clinical investigation, please give details of other countries that will be or have been approached. This should include all European and Non European countries. 4. Manufacturer's statement All notifications must be prefaced by this statement signed by the manufacturer's duly authorised signatory. The statement should be signed by an appropriate employee of the manufacturer of the medical device under investigation or the authorised representative appointed by the manufacturer. Part 2: Manufacturer Information Integrated Research Application System (IRAS) 2

3 5. Manufacturer Please give the full name and address of the manufacturer of the medical device under investigation. "Manufacturer" means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. In cases where the investigational medical device will be CE marked and placed on the market under the name of a third party who is yet to be identified, the organisation that is responsible for developing the device and is undertaking the clinical investigation should sign this statement. 6. Manufacturer's authorised representative A manufacturer who does not have a registered place of business in the EU is not expected to have appointed an authorised representative until the device is placed on the market. However, if an authorised representative has been appointed at this stage please provide details. Part 3: Device Information For any clinical investigation requiring notification to the Competent Authority, please give details of each investigational medical device. This includes any CE marked medical devices that are being used for a new purpose in this clinical investigation and all medical devices that are not CE marked. To create additional fields in this part of the PCA1 form for more than one device, please go to Part B Section 2 of the integrated dataset for your project and click on the button "Add another investigational device" under Question 2 in sub section A. This will open additional fields within Part B Section 2 which will populate form PCA1. 7. Manufacturer's trade name Please provide details of the trade name associated with the device. 8. Notified Body approval of quality system or process Integrated Research Application System (IRAS) 3

4 If a Notified Body has been appointed by the manufacturer of the investigational device please provide the 4 digit reference number unique to the Notified Body appointed and provide details of the scope of the certification issued by the Notified Body. 10. Generic name Please provide details of the generic name used to describe the principal intended use of the device. 11. Class of device General Medical Devices this should be the classification of the device which has been determined using the Classification Rules in Annex IX of the Medical Devices Directive 93/42/EEC. Active Implantable Medical Devices please select AIMD. Part 4: Clinical Trial Information 12. Number of devices in the trial Please give the number of devices that will be available in the UK clinical trial and the total global number if the trial is multi country. If there is more than one investigational device, please state the total number and then give the breakdown between each device in the "further details" boxes. 14. Trial monitor If a study monitor has been appointed for this trial please provide details. 15. UK contact point Integrated Research Application System (IRAS) 4

5 Give details of the most appropriate person who will be able to respond to questions from the Competent Authority. This should normally be a UK contact point, but if your preferred contact is based outside the UK please provide their contact details. 16. Fee payable to the Competent Authority Details of the fee payable can be found on the MHRA website at the link below. Please note that the fee given in brackets is only applicable to re submitted applications Application to Research Ethics Committee If you do not know which Ethics Committee you will be applying to at the time of application to the Competent Authority please leave this section blank and inform MHRA once available. However, please sign the statement at Q18 allowing MHRA to contact the ethics committee if you are happy to authorise this now. Part 5: Clinical Investigators and trial sites 19. Single site or multi site trial? Please indicate whether this will be a single site or multi site trial in the UK. This question is only applicable to the number of sites in the UK. 20. Principal Clinical Investigator The Principal Clinical Investigator (PCI) will normally be the same person named as "Chief Investigator" (CI) for the purpose of the REC application in Question A2 of IRAS. However, for MHRA purposes the PCI may be based outside the UK. There may exceptionally be cases where the PCI is a different person from the UK based CI named in the REC application. Integrated Research Application System (IRAS) 5

6 21. Additional Clinical Investigators Please provide details of all UK investigators (in addition to the Principal Clinical Investigator) participating in this clinical trial. FORM PCA2 Please indicate in the boxes provided where information on each point can be found in the documentation to be submitted to the Competent Authority. STERILISATION ANNEXES Where applicable, information on the method of sterilisation employed and the validation documentation must be provided for all components of a system and any accessory devices, as well as for each investigational device. To create additional Sterilisation Annexes for another component of the device system or an accessory device: Go to Part B Section 2 of the integrated dataset for your project Select sterilisation pro forma(s) Click on the button "Add sterilisation details for another device or component" at the top of the page. Enter additional data for the device/component this will then be populated to a new Sterilisation Annex. To create additional fields for more than one investigational device (any CE marked medical devices being used for a new purpose in this clinical investigation and all medical devices that are not CE marked): Go to Part B Section 2 of the integrated dataset for your project Click on the button "Add another investigational device" under Question 2 in sub section A. Enter additional data for the device this will then be populated to Form PCA1. Integrated Research Application System (IRAS) 6

7 A sterilisation proforma will automatically be generated to provide sterilisation details for the device in Part B Section 2 and a new Sterilisation Annex will be created. IRAS QSG MHRA Devices Forms Version 2.2 Updated April 2009 Integrated Research Application System (IRAS) 7