Applicant Guide: Consideration of study protocols by HSE
Introduction & Background
HSE's Chemicals Regulation Division (CRD) is often asked to comment on draft study protocols in order to confirm that the design and methodology is appropriate and will potentially address a specific data gap. This is particularly the case for more complex higher tier studies for which some novel method or approach is necessary that is not covered by existing guidance.
In light of the work involved in assessing such requests, and the detailed discussion that often takes place between CRD specialists and the applicant, it is considered appropriate to recover the costs associated with this work through the charging of a fee proportionate to the work involved.
Consequently such requests are considered via submission of an application to the Applications sift: firstname.lastname@example.org.
What Information should I submit?
- A covering letter clearly laying out the context of the proposed trial and its objectives including any specific data requirements it is designed to address. The covering letter should also detail all relevant information (eg GAP or conditions of application that you are seeking to support), clearly specify the questions you would like to be answered and clarify who is applying and the address for invoicing.
- The draft trials protocol.
What fees will I be charged?
The following fees will be charged which reflect the work involved in commenting on trial protocols.
- Sift fee
- Reasoned Case fee (For particularly complex studies requiring significant specialist input it may be necessary for CRD to charge an additional data module fee in the relevant specialist area to fully recover the costs associated with this work. CRD will advise the applicant in advance of applying this additional fee should it become necessary).
- Further information on Fees
Timescales and outcome
- CRD's assessment of draft protocols will take no longer than 4 weeks to produce. You will be provided with a copy of our conclusions and recommendations upon completion.
- Please note that our consideration of the protocol does not guarantee the outcome of the study or that it will adequately address the relevant data requirement.
- It should also be noted that CRD's conclusions represent a UK point of view and that other Member States may have different opinions.