St James's Hospital
Research & Development Hub
Research & Development Application / Registration Form
*  Mandatory Field
This form must be completed before starting any form of planned research related project to register the study and for approval, if required. Please note that this form must be completed in one go. It cannot be saved and returned to.
1. Submitted by / Contact for the study Fill out sections 1 and 2 if you are the contact for the study but not the PI. If you are the PI, only fill out section 1, and skip section 2.
* Title: * Full Name: * Contact No: Enter number only with no spaces or symbols
* Email: * Work Position: e.g. SHO, consultant, nurse, manager, senior therapist, etc. * Specialty/Sub-Area: e.g. cardiology, respiratory, etc.
* Organisation:    Other:
   Personnel No: For St. James's Hospital Staff.    Directorate:    Department:
2. SJH Principal Investigator / SJH Supervisor (If different from above) The PI is the lead researcher and individual responsible for the on-site conduct of the study. The PI should be a hospital consultant for large studies (e.g. clinical trials, medical device trials, funded studies and clinical research at the level of Masters or above). Smaller studies can be run by researchers with the approval of local managers. External researchers require a local hospital based PI, collaborator or supervisor. Please note that the PI selected will receive a notification email for approval.
   Title:                Full Name:            Enter Email:                 
   Contact No:Enter number only with no spaces or symbols Work Position:       Specialty / Sub-Area:    
3. Co-Investigators / Research team (add if applicable)
 Full Name:  Work Position:  Organisation:  Role on Study:
4. Title
* Title of Study:  
5. Research type
* Type of research project: See associated guidance manual for description of research types. Other: 
   EudraCT Reference Number:For Clinical Trials / Drug Trials only    Legal Sponsor:  
   Is HPRA approval required:    Pharmacy used to manage drugs / IMP:   
   HPRA approval applied for:    HPRA approval received:   
* Is ethics approval required: Research involving patients, patient data or patient samples, usually requires ethical approval. Staff related research, audits and quality improvement projects do not usually require ethics approval.
   If yes, has ethics approval been applied for:
   If yes, has ethics approval been received:
* Is the study part of an academic qualification:       Other:  
6. Study Details
* Estimated start date: / / Calendar
* Estimated data collection end date: / / Calendar
* No. of planned participants
   (subjects, samples or charts): Enter the planned number of participants in the case of a patient or staff study, and the number of patient charts, EPR, PAS records, etc., to be accessed in the case of an audit or chart review.
* 7. Lay summary of the proposed research activity: (250 words approx) Include a study description referring to the background, aims, hypothesis, participants, testing, etc.
8. Location
* Will the study be run in conjunction with
   the St. James's Clinical Research Facility (CRF):
   If no, please comment:  
* Where will the research take place: Note the main data collection site, e.g. ICU, OPD, or Ward of Department in the case of an audit.    Specify Location:
       SJH Department / Location:
* Is this a multi-site study: Are there other hospitals or centers involved?    If Yes, which is the lead site:  
     If Yes, who is the overall PI:  
9. Funding
* Is there funding available for this study:     
   If Yes, what is the planned amount of funding:    
   If Yes, what is the funding source:       
   If Yes, where will the funding be held:           Specify Location:  
* 10. Resources:
 What hospital resources will be used: (estimate quantity)
 Lab (test type & no):    Staff time:    CRF:  
 Diagnostics (type & no):    Pharmacy:    CAMI:  
 Procedures (type & no):    Equipment:    Chart Room:  
 Consumables:    Room Use:    Other:  
11. Other
   Any other comment about this submission:            
12. Declaration Line manager / ward manager agreement is required for most types of research.
* Is local notification / approval required (e.g. from Manager):    
   If Yes, has approval been received, and by whom?         by:         
* I confirm that the information provided herein is accurate, discloses the ethics requirements and grant/funding provisions applicable to the
   proposed research activity, and that all relevant parties have been notified:
* I agree to comply with the data protection requirements of conducting research at St. James's Hospital, as per the SJH Information Management Policies: