Docstoc

Effective_site_visit_with_sponsor

Document Sample
Effective_site_visit_with_sponsor Powered By Docstoc
					Check out the check list for an effective site visit with the sponsor

Self Management (Sponsor’s escort)

   □   Always read the profile of the sponsor before meeting
   □   Make sure that the study room is kept clean and tidy
   □   Take prior appointment with PI and all people whom you plan to meet at the site
   □   Be well versed with the route to the site
   □   Estimate and inform on total time required for the visit
   □   Prepare for some general discussions ( about the city - total population , famous
       places, current news, it will make the work interesting)
   □   Keep contingency plan ready incase of some delays ( visit to OPD etc, to show
       that you value yours and your customers time)

Information Management

   □   Should have all possible information about the PI.
   □   Should be aware about ethics committee ( internal or external , frequency of
       meetings its fees)
   □   Should have the basic information of the site (key high lights of the site, its
       location, how many beds, various specialties, patient pool, and key people and
       contact at the site
   □   Have good understanding of important locations at the site (PI’s room, CT room,
       Lab, Inpatient ward, Examination room, OT etc)
   □   Should have knowledge about the equipments and facilities available at the site
       for trials (fax, centrifuge, internet, refrigerator, any other- trial specific) and
       should be able to present them well.
   □   Basic Information’s on other trials (Not competitive), where we can get patients
       from cross referrals for this trial
   □   Site specific procedures like where patient get registered for the first time, basic
       procedures on how the patients are being segregated to their ailments
   □   Information on patient load from different regions

PI Management

   □   Always brief PI about the background of the sponsor
   □   Just Mention to PI, approx time the meeting will take
   □   Equip the PI with relevant information about the trial (correct indication and
       inclusion exclusion criteria if possible)
   □   Ask him to highlight during discussion with sponsor what all will make this site
       a good choice for the trial
   □   And also ask PI to brief the sponsor about importance of SMO
   □   PI can update the sponsor about the site, percentage of patients and the current
       therapy procedures the PI handling for that indication

   Optional (if asked by the sponsor then)
Infrastructure
   □   Take sponsor to existing CT room to show how the data is managed and kept
       safely (locked and restricted access)
   □   Make sure things are organized at CT room
   □   Show them patient pool from OPD (if in hospital or nursing home)
   □   Show them some key features of the site (special facility available).

Don’ts
   □   Fake any information about the site or self
   □   Give irrelevant information about the site (eg a kidney transplant that happened
       at the site just because it brought the site in news)
   □   Force the sponsor into any discussion, activity etc.
   □   Take sponsor for a lavish lunch and spend more time there rather then the site
   □   Create monologue where just you are speaking
   □   Do not be nervous and panic
   □   Oversell the site

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:95
posted:8/22/2010
language:English
pages:2