Our main purpose is to help the Pharmaceutical Companies and Contract Research Organizations to find the right Physician Investigator to assure the rapid and accurate completion of the clinical trial.
Valuable Investigators Database Concept Research
Pre-Study Assessmen Questoinnaire
Country: ROMANIA City: .......................... Participant name: .......................... Participant speciality: .......................... Participant title: .......................... Practice: □ Private □Public □Hospital □Specialized Clinic □SMO □Other……….
Institution name: .......................... Institution address: .......................... Phone number: .......................... Fax number: .......................... E-mail: ..........................
Trial Experience
1.Have you participated as an investigator (PI or sub-I) in any previous clinical trials? ( ) Yes ( ) No
2.If yes, please indicate the number of trials: …………………………………………………
3.If yes, please provide indication : ………………………………………
4.Please also, provide if possible the companies name(CROs or Sponsors) with you work it: ………………………………………………………………………………………………......
5.Are you, as a PI, participating in any current trials? ( ) Yes ( ) No
6.If yes, please provide the number: ……………………………………………
7.If yes, please provide the indication: ………………………………………………
Location
8.Location where study subjects are seen: Center Name ............................. Town/City .................................
9.Will subjects be seen at multiple locations? ( ) Yes ( ) No
10.If your site is part of an investigator network, please choose response below: ( ) Site management organization ( ) Academic investigator network ( ) Medical Networks ( ) Other type of investigator network (specify)
11.Please list name of network: ………………………………...............……
12.Did your site have a special room with freezer and refrigerator for study medication, with limited acces? ( ) Yes ( ) No Comments :……………………………………………………………………………
13.Did your site have from MoH the Clinical Trials Authorisation? (Please answer to this question only if you don’t have clinical trials experience) ( ) Yes ( ) No Comments :……………………………………………………………………………
14.At your site do you have special cabinets for keeping the trials documentations with limitted access? ( ) Yes ( ) No Comments :……………………………………………………………………………
Site organization:
15.How many MDs at your site are engaged in clinical research ? …………………………………………………………………………
16.How many study nurses are involved in clinical trials at your site? (Full time / Part time) ……………………………………………………………………………………….....................
17.How many study coordinators are at your site? (Full time / Part time) ………………………………………………………………………………..
18.Is your site used to work with a central laboratory? ( ) Yes ( ) No
19.Is courier service at your site reliable? ( ) Yes ( ) No
20.Which dedicated staff will be made available for a trial? ( ) Sub-Investigators ( ) Trial Nurse ( ) Trial Coordinator ( ) Data Manager ( ) Regulatory Contact ( ) Pharmacist ( ) Lab Personnel for Sample Processing ( ) Other (Please Specify)
21.Do you ever experienced any audit from sponsor or regulatory inspections? ( ) Yes ( ) No
22.How many audits or inspections do you experienced by now? ………………………………………………………………………
23.When was the last audit or regulatory inspections at your site? …………………………………………………………………………
Equipment & EDC
24.Are you familiar with Eletronic Data Capture(EDC) systems? ( ) Yes ( ) No
25.If your site has used electronic data capture (EDC) before, what systems have you used? ( ) Oracle Clinical - RDC ( ) INFORM (PhaseForward) ( ) eClinical Trials ( ) RAVE (Medidata) ( ) Don't know name of system used ( ) Other (Please provide name of system) [ ………………………. ]
26.If you have used EDC before, what systems did you like and what systems did you dislike? ……………………………………………………………………………………….......................…
Adverse Events Experience
27.Have you at your site ever experienced a SAE (Serious Adverse Event) or other critical challenge during your research experience? ( ) Yes ( ) No
28.Do you know all the GCP subject related procedures for solving and close any possible appeard SAE? ( ) Yes ( ) No
Patient Population
29.Please if possible, please estimate the number of patients that your hospital serves? ………………………………………………………………………………….....................
Recruitment
30.What would be your main source of subjects for this trial? ( ) Physician referrals from the community ( ) Your own patient database ( ) Other (Please specify)
31.Would you be willing to utilize advertising/recruitment materials for this trial? ( ) Yes ( ) No
32.If yes, please check those you'd be willing to use (if EC/IRB approved): ( ) Patient leaflet providing education about clinical trials in general ( ) Patient leaflet - trial specific ( ) Appointment reminder cards ( ) Template letters that may use to send to community physicians to seek referrals ( ) Internet postings such as CenterWatch ( ) Speaking engagements ( ) Other (Please specify)
33.Does your institution post open clinical trials to a publicly accessible website? ( ) Yes ( ) No
34.If yes, please provide name of the website: ……………………………………………………
35.What types of recruitment materials have you used in the past (e.g. internet postings, patient flyers, referral letters)? ………………………………………………………………………………………….................................................
36. Do you have performed in the last year an ICH GCP training ? ( ) Yes ( ) No
Facilities
37.Please describe below wich of the following facilities do you have access to? ( ) Computer Tomography (CT) ( ) RMI ( ) Echo doppler ( ) Echo cardiography ( ) EKG ( ) Weight measurement ( ) X-Ray ( ) ................................ |
Dear participant thank you very much for giving us a more deep insight into the acceptance and practicability of the planned clinical study and your potential for participating. Please don’t hesitate to give us any further comments to the planned project.
All your answers will be summarized and reported anonymously on a per country basis.
PERSONAL DATA OR PRIVACY PROTECTION
Please be advised that VID Concept Research must track and electronically maintain certain information associated with Investigators and sites in order to perform
expected duties on behalf of its Sponsors, such as Investigator selection and ongoing project management. In compliance with applicable personal
data protection or privacy principles, VID Concept Research is hereby informing you that personal information you provide to us may be maintained in this way and
may be transferred to the Sponsor, or other regulatory bodies. The information to be maintained includes, but is not limited to the following:
• Investigator name and contact information
• Other relevant information to allow selection for appropriate projects in the future
