Managing a Research Project Alasdair MacLullich MRC Clinician Scientist Fellow Hon Consultant in Geriatric Medicine

Overview Projects vs clinical work (Question, protocol) Detailed protocol development Setting up Getting started Running the project Concluding the project 3

Projects vs clinical work What is a project? Unique Temporary Specific outcomes Has a timeline 4

Projects vs clinical work Project Management Formal approach Specialist area Anyone doing a project can benefit from using some kind of formal approach Courses/books are useful 5

Question(s), protocol Question Protocol Clear, important, answerable, planned analyses Protocol At early stages often an overview Will usually need more detailed development 6

Detailed protocol development Moves from outline to detailed planning Step-by-step analysis Flowchart is essential Allows identification of possible hitches early Allows identification of steps that need to be taken early Detail on conduct of project is required for ethics and R&D 7

Setting up 8

Setting up Documentation Protocol Information sheets and consent forms for participants Information sheets for clinical staff (eg. GP letters) Data recording forms 9

Setting up Ethics Needs care and time Essential to know timelines: check corec.org.uk Mostly straightforward if preparation done NB documentation required for study anyway R&D Occurs in parallel with ethics, takes a few weeks 10

Setting up Laboratory work Licensing for animal work Health and safety – labs have comprehensive procedures 11

Setting up Training Self or others Formal approach is helpful Develop paperwork and practise Check that quality of assessments are high enough Legal requirements (eg. hon contracts, health and safety) 12

Setting up Other team members Supervisor Statistician Collaborators 13

Setting up Ward staff Mostly very helpful But busy with core work and protective of patients Courteous and timely communication is important Inform senior staff (charge nurses, consultants, managers) in advance Need clear story of what you are doing Consider carrying letter of introduction ID badges for research staff 14

Setting up Setting up the database Excel adequate for small projects Better to use stats program or data entry program for bigger/complex projects The more categories the better Naming variables Think about the analysis Who is going to be entering the data? 15

Getting started 16

Getting started Walk-through With flowchart, check: All documents in place All relevant people aware Do virtual walk-through, preferably with team Do actual walk-through on site(s) of project Set a start date Send this to all collaborators 17

Running the project Start slowly Keep a ‘lab book’ record of progress eg. comments from patients & staff Seek regular feedback from any staff Maintain overview (vs day to day work) Regular communication with collaborators Data entry: keep up with this, check accuracy 18

What if things go wrong? 19

Running the project What if things go wrong? Eg. Recruitment is poor Some instruments (eg. rating scales) not working Assessments taking too long Findings are far from what is expected Assessments clash with ward work 20

Running the project What if things go wrong? Allow some time to pass (need a few goes to be sure) Discuss with supervisor Consider altering the protocol, eg. sites or recruitment, exclusion criteria, no. of assessments Most protocol changes require ethics/R&D approval: takes 3-4 weeks Always have an overview of the whole project and where it is going 21

Concluding the project Set a finish date Make a plan for writing-up Thank all people involved Communicate with collaborators, etc. Report to ethics Disseminate! 22

Overview Projects vs clinical work The overall project plan (Question, protocol) Detailed protocol development Setting up Getting started Running the project Concluding the project 23

Resources www.bgs.org.uk UoE Geriatric Medicine Unit UoE – statisticians, collaborators UoE/NHS courses Wellcome Trust Clinical Research Facility 24