Compiling your application
To begin with your application you will need to provide
at least three core documents for your submission: (i) Study Protocol, (ii) Participant Information Sheet (PIS), and (iii) Informed Consent Form (ICF).
Guidance and templates are provided below to assist you with the application process, but you are also welcome to use your own forms.
>>
Study Protocol Study_Protocol_v1.4_Guidelines.pdfStudy_Protocol_v1.4_Template.docx>>
Participant Information Sheet (PIS)PIS_v1.4_Guidelines.pdfPIS_v1.4_Template.docx>>
Informed Consent Form (ICF)ICF_v1.4_Guidelines.pdfICF_v1.4_Template.docxAdditional documents and requirements?
If you are advertising your study or recruiting participants in any way, you will need to provide these documents also. Key personnel you list in your Study Protocol and ICF will also need to provide CVs so the committee can determine their suitability to undertake the role/s assigned to them. Here is a non-exhaustive list of some examples of documents you might need to add - depending on your study design:
>> Staff CVs (E.g. for CI/PIs/Study Co-ordinators)
>> Debriefing sheets
>> Training records
>> Compliance documentation
>> Recruitment adverts or letters
If anything crucial to your application is missing, the intial quality control review will flag this up and you will have the opportunity to share this again.
What next?
STEP 01
Prepare your three core documents: (i) Study Protocol, (ii) Participant Information Sheet (PIS), and (iii) Informed Consent Form (ICF).
STEP 02
Consider any additional material you will need to attach to your application and prepare this also.
STEP 03
Click on Start Application below. During the submission process you will have the opportunity to upload all the files you have prepared from STEP 01 and STEP 02.
