When you're preparing your application in new IRAS, you'll need to upload supporting documents and assign them to a suitable document type using the dropdown menu in the system.
This table is to help you select the right option from the menu for each document. It also shows which documents are mandatory for IRAS verification or required for regulatory review, and which review body each is sent to when you submit your initial application.
For guidance on how to upload documents in the system, please see the IRAS user guide.
Document list for combined review applications in new IRAS
| Document type | Description | Mandatory or required | Review body it's sent to |
| Cover letter | The cover letter is an opportunity to include information not already included elsewhere in the submission. Make sure your cover letter includes the IRAS ID. The MHRA provides further guidance on what to include in your cover letter for initial submission. Find this at gov.uk: https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#documents-to-send-with-your-application | Mandatory for submission of an initial application, amendments, development safety update reports (DSURs) and urgent safety measures (USMs). |
MHRA REC and/or study-wide review |
| Protocol | The protocol is a full description of your research study. It acts as a manual for the research team at research sites to ensure adherence to the methods outlined. The HRA provides some protocol development tools and templates at https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/ | Mandatory for submission of an initial application. |
MHRA REC and/or study-wide review |
| Summary of scientific advice/PIP opinion | Where you have sought scientific advice, you should upload evidence of the outcome. Where you have a paediatric investigation plan (PIP), you should upload the PIP opinion. | Not mandatory. | MHRA |
| Investigator Brochure/SmPC | The Investigator Brochure is a summary of the clinical and non-clinical data relating to an investigational medicinal product (IMP). The Summary of Medicinal Product Characteristics (SmPC) describes the properties and approved conditions of use of an IMP. | Required for submission of an initial application. |
MHRA REC and/or study-wide review |
| Authorisation of manufacturing and import/QP GMP Certification | You’ll need to upload the Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP)), for manufacturing sites within the UK or EU and Qualified Person (QP) declaration on good manufacturing practice for manufacturing sites outside the UK or EU. Find this good practice on gov.uk at https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice. For more information, see the MHRA website on gov.uk at https://www.gov.uk/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries/importing-investigational-medicinal-products-imp-from-countries-on-a-list-to-great-britain | Required for submission of an initial application, unless only licensed products are being used and trial labelling is performed under the exemption from the need to hold a manufacturer’s authorisation. | MHRA |
| IMPD | The Investigational Medicinal Product Dossier (IMPD) is a summary of the IMP chemistry, manufacturing and control (CMC) information. The MHRA provides some example IMPDs, setting out the minimum requirements at https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk. An active substance master file (ASMF) is not acceptable as a substitute for an IMPD. | Required for submission of an initial application where an SmPC has not been supplied. | MHRA |
| AMPD | The Auxiliary Medicinal Product Dossier (AMPD) is a summary of the auxiliary medicinal product chemistry, manufacturing and control (CMC) information. | Not mandatory. | MHRA |
| Content labelling of the IMPs | Provide an example of the label, or confirmation of the label content, for all the investigational medicinal products (IMPs). Where there is a proposal not to use clinical trial labelling, upload a document with a justification for its absence. | Mandatory for submission of initial application. | MHRA |
| Proof of insurance |
This refers to the certificate of insurance or indemnity. It should be in date at the time of submission. It’s only required for studies sponsored by non-NHS/HSC organisations. For studies sponsored by an NHS/HSC organisation, additional insurance is not usually needed, and evidence of insurance or indemnity is not usually required. Where no additional insurance is in place for such a study, upload a Word document stating: ‘This study is sponsored by an NHS/HSC organisation and no additional insurance for design or management of the research is required’. |
Mandatory for submission of initial application. | REC and/or study-wide review |
| Financial arrangements | There is a separate form ‘Letter from Funder’. Any other supporting documents related to financial arrangements can be uploaded here but it may not be necessary for your study. | Not mandatory. | REC and/or study-wide review |
| Suitability of the clinical trial sites facilities | This is a written statement on the suitability of the clinical trial sites adapted to the nature and use of the investigational medicinal product (IMP). | Not mandatory. | REC and/or study-wide review |
| Recruitment arrangements | There are separate document types for ‘participant information and informed consent forms’, ‘copies of materials calling attention of potential participants to the research’ and ‘letters of invitation to participant’. Any other supporting documents related to recruitment arrangements can be uploaded here but it may not be necessary for your study. | Not mandatory. | REC and/or study-wide review |
| Participant information and informed consent form | Where there are more than one information sheet or consent form, especially for studies that have different arms or patient populations, make it clear in the description field for each document uploaded. See the HRA guidance around information sheets and consent forms at https://www.hra-decisiontools.org.uk/consent/content-sheet-involved.html | Mandatory for submission of an initial application. | REC and/or study-wide review |
| Suitability of the investigator/Investigator CV | The CV should demonstrate that the investigator is qualified by education, training and experience to conduct the research. The HRA provides a template suitable for submission of CVs by Chief Investigators, Principal Investigators and Academic Supervisors. Find this at: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/prepare-study-documentation/ | A copy of the Chief Investigator’s CV is mandatory for submission of an initial application and submission of an amendment to change the Chief Investigator. | REC and/or study-wide review |
| EudraCT XML | XML version of the EudraCT form. | Not mandatory. |
MHRA REC and/or study-wide review |
| EudraCT PDF | PDF version of the EudraCT form. | Not mandatory. |
MHRA REC and/or study-wide review |
| Miscellaneous: MHRA & non-MHRA | This refers to any other supporting documents that need to be reviewed by the MHRA and REC or study-wide reviewers. The description should make the content of the document clear. | Not mandatory. |
MHRA REC and/or study-wide review |
| Miscellaneous: MHRA-only | This refers to any other supporting documents that need to be reviewed only by the MHRA. The description should make the content of the document clear. Examples include Data and Safety Monitoring Board (DSMB) review decisions, data summaries or Helpline communications. | Not mandatory. | MHRA |
| Miscellaneous: non-MHRA only | This refers to any other supporting documents that only need to be reviewed only by the REC or study-wide reviewers (not MHRA). The description should make the content of the document clear. | Not mandatory. | REC and/or study-wide review |
| Proof that data will be processed in compliance with union law on data protection | This document type is no longer required. | This document type is no longer required. | This document type is no longer required. |
| Certificate of analysis | This document should list the test results for the IMP. | Not mandatory. | MHRA |
| Clinical summary results |
This is an end of study document. If your clinical trial is not on a public register, summary results should be submitted to the MHRA. See the MHRA website for further information at https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#end-of-trial |
Required at the end of trial. | MHRA |
| Confirmation of EudraCT number | Confirmation of EudraCT number is no longer required. | This document type is no longer required. | This document type is no longer required. |
| Copies of materials calling attention of potential participants to the research | Previously known as ‘Copies of advertisement materials for research participants'. This includes any supporting documents used to help with participant recruitment other than participant information sheets, consent forms and invitation letters. | Not mandatory. | REC and/or study-wide review |
| Dear investigator letter | A letter to participating investigators regarding important updates to the study. | Not mandatory. |
MHRA REC and/or study-wide review |
| Details of any data monitoring committee | A data monitoring committee (DMC) may be established by the sponsor to assess at intervals, the progress of a clinical trial, the safety data, and the critical efficacy endpoints. This document should detail who makes up the DMC and which members are independent of the study. It should also be clear what the DMC schedule is and how their findings may impact the study. | Not mandatory. | REC and/or study-wide review |
| DSUR report | Development Safety Update Reports (DSURs) should be uploaded when submitting a DSUR. | Mandatory for DSUR submissions. | MHRA |
| GLP documents | This refers to supporting documents where a facility needs to comply with good laboratory practice (GLP) regulations. See the MHRA guidance on gov.uk at: https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals | Not mandatory. | MHRA |
| GMP documents | Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. | Not mandatory. | MHRA |
| GP/consultant information sheets or letters | All letters or information sheets for GPs or other health and social care professionals should be uploaded. The description should be clear if studies have different arms or different sheets or letters. | Not mandatory. | REC and/or study-wide review |
| Instructions for use of medical device | These are instructions which will be provided to participants (instructions to clinicians do not need to be submitted). | Not mandatory. | REC and/or study-wide review |
| Interview schedules or topic guides for participants | Interviews and topic guide documents should list questions or areas for discussion. | Not mandatory. | REC and/or study-wide review |
| Letter from funder | Copy of relevant funding letters for studies applying for Network Support. | Not mandatory. | REC and/or study-wide review |
| Letter from statistician | Where statistical aspects of the research have been reviewed by a statistician, upload a copy of any available comments or reports. | Not mandatory. | REC and/or study-wide review |
| Letters of invitation to participant | This refers to invitation letters which will be sent to potential participants. | Not mandatory. | REC and/or study-wide review |
| List of competent authorities submitted to | For international studies, this would include other competent authorities that will be reviewing the studies. | Not mandatory. | MHRA |
| Manufacturer authorisation | This document type should not be used. Use the document type ‘Authorisation of manufacturing and import/QP GMP Certification’. | This document type should not be used. Use the document type ‘Authorisation of manufacturing and import/QP GMP Certification’. | This document type should not be used. Use the document type ‘Authorisation of manufacturing and import/QP GMP Certification’. |
| Non-NHS/HSC Site Assessment Form | The Non-NHS/HSC Site Assessment Form is used when a clinical trial of an investigational medicinal product (CTIMP) and/or medical device study is taking place in a non-NHS / non-HSC setting. For further information and to obtain the template document, refer to the guidance on IRAS Help at: https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx#non-NHS-sites | Not mandatory. | REC and/or study-wide review |
| Non-validated questionnaire | Questionnaires should be uploaded individually with the name of the questionnaire entered in the description. If the questionnaire will be used in both paper and electronic formats, only one version needs to be submitted. | Not mandatory. | REC and/or study-wide review |
| Organisation Information Document | The Organisation Information Document is a key component of the UK Local Information Pack, further information is available on IRAS Help at https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack-OID. You should upload the outline Organisation Information Document. Where there is more than one, provide a description for each type. | Not mandatory. | REC and/or study-wide review |
| Outline of active trials | This document should contain a list of previous clinical trials (completed or ongoing) with the same IMP. | Not mandatory. | MHRA |
| Referee's report or other scientific critique report | Where scientific aspects of the research have been reviewed, upload a copy of any available comments or reports. | Not mandatory. | REC and/or study-wide review |
| Response to request for further information | This document type should not be used. | This document type should not be used. | This document type should not be used. |
| Safety review report | This document type is not required. | This document type is not required. | This document type is not required. |
| Sample diary card/patient card | All diary/patient card samples should be uploaded. | Not mandatory. | REC and/or study-wide review |
| Summary of any applicable exclusions to sponsor insurance (non-NHS sponsors only) | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. |
| Validated questionnaire | Questionnaires should be uploaded individually with the name of the questionnaire entered in the description. If the questionnaire will be used in both paper and electronic formats, only one version should be submitted. | Not mandatory. | REC and/or study-wide review |
| Letter from sponsor | This refers to a letter from the sponsor confirming that they will take on the role of sponsor. | Not mandatory. | REC and/or study-wide review |
| Annex 2: Notification of Amendment/Amendment tool |
All amendments require a completed and locked PDF of the Amendment Tool. The tool is available from: https://www.myresearchproject.org.uk/help/hlpamendments.aspx#Amendment-Tool |
Mandatory for each amendment submission. |
MHRA REC and/or study-wide review |
| Local Information Pack template | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. |
| mCTA | For research involving NHS sites, you need to submit the agreement you intend to use for study wide review purposes. It’s strongly recommended that model contracts or agreements are used unmodified. Where they are modified this should be highlighted and justification provided. Further guidance and templates are available on IRAS Help at: https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx#Contracts-Agreements | Not mandatory. | REC and/or study-wide review |
| Schedule of Events/SoECAT | A Schedule of Events or a SoECAT is required for all non-commercial studies with participating NHS/HSC organisations where a UK Local Information Pack is required. You need to provide one SoECAT or Schedule of Events per outline Organisation Information Document. These should be uploaded as excel documents. Further guidance and templates are available on IRAS Help at: https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack-SoE-SoECAT | Not mandatory. | REC and/or study-wide review |
| Sites Document | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. | This document type is no longer required to be uploaded with the submission. |
This table might not be accessible to all users, if you need the information in another format please contact communications@hra.nhs.uk