I-ACT for Children Site Network Questionnaire

Site Network Questionnaire

Hospital Name

Legal Name of Entity (if different from above)

Address 1 *

Address 2

City *

States

Zip code *

Point of Contact

First Name *

Last Name *

Title/Role *

Degree(s) *

Email *

Phone *

Address 1 *

Address 2

City *

State

Zip Code *

Physician Site Champion

First Name *

Last Name *

Title/Role *

Degree(s) *

Email *

Phone *

Fax

Address 1 *

Address 2

Address 3

City *

State

Zip Code *

Please identify who is completing this form

First Name *

Last Name: *

Email *

Phone *

Fax

Section 1: General Information

5. What percentage of each racial background best composes your center’s population of care (amounts in the boxes should sum to 100%):

a. American Indian or Alaskan Native *

b. Asian American *

c. Black or African American *

d. Native Hawaiian or Pacific Islander *

e. White or Caucasian American *

6. What percentage of Non Hispanic/Latino ethnic background best composes your center’s population of care (amounts in the boxes should sum to 100%):

a. Hispanic of Latino *

b. Not Hispanic of Latino *

7. For International Sites please complete (describe the background of your population served below):

8. Are you a birthing hospital / facility? *

Yes

No, but affiliated with/access to a birthing facility

9. Is your Institution part of a Clinical and Translational Science Award (CTSA) or Clinical and Translational Science Institute (CTSI)? *

Yes

If yes, do you utilize any of the core services? *

Yes

10. Which phases of clinical trials are your research teams capable of participating in? *

Phase 1

Phase 2

Phase 3

Phase 4

Other 1 *

Other 2 *

12. Does your site have an established parent/child advocacy or engagement group with knowledge or experience in pediatric clinical trials? *

Yes

It is a work in progress

Section 2: Satellite Site Information

Section 3: Contact, IRB & Other Review Information

Step 1: Please identify any and all areas in which your site conducts clinical trials by checking the box to the left, next to the sub-specialty.

Step 2: Please indicate the Top 5 Therapeutic Areas (from the list above) in which your site highly performs, has highly engaged principal investigators and research staff, achieves enrollment targets in most projects, etc.

We would like to obtain performance data about the 5 key areas you identified as your site’s research strengths. Would you please provide the following:

Sub-specialty 1

Specialty Area / Question 1 *

a. In the past year, how many studies were conducted in this area *

b. # of Investigator Initiated Studies- not sponsored funded *

c. # of Investigator Initiated Studies- sponsored funded *

d. # of Investigator Initiated Device Studies- not sponsor funded *

e. # of Investigator Initiated Device Studies- sponsor funded *

f. # of Industry Sponsored Trials *

g. # of Industry Sponsored Device Trials *

h. Was your site able to reach it's enrollment for this sub-specialty? *

Yes

If not, please provide a brief explanation *

Sub-specialty 2

Specialty Area / Question 2: *

a. In the past year, how many studies were conducted in this area *

b. # of Investigator Initiated Studies- not sponsored funded *

c. # of Investigator Initiated Studies- sponsored funded *

d. # of Investigator Initiated Device Studies- not sponsor funded *

e. # of Investigator Initiated Device Studies- sponsor funded *

f. # of Industry Sponsored Trials *

g. # of Industry Sponsored Device Trials *

h. Was your site able to reach it's enrollment for this sub-specialty? *

Yes

If not, please provide a brief explanation *

Sub-specialty 3

Specialty Area / Question 3 *

a. In the past year, how many studies were conducted in this sub-specialty? *

b. # of Investigator Initiated Studies- not sponsored funded *

c. # of Investigator Initiated Studies- sponsored funded *

d. # of Investigator Initiated Device Studies- not sponsor funded *

e. # of Investigator Initiated Device Studies- sponsor funded *

f. # of Industry Sponsored Trials *

g. # of Industry Sponsored Device Trials *

h. Was your site able to reach it's enrollment for this sub-specialty? *

Yes

If not, please provide a brief explanation *

Sub-specialty 4

Specialty Area / Question 4 *

a. In the past year, how many studies were conducted in this sub-specialty? *

b. # of Investigator Initiated Studies- not sponsored funded *

c. # of Investigator Initiated Studies- sponsored funded *

d. # of Investigator Initiated Device Studies- not sponsor funded *

e. # of Investigator Initiated Device Studies- sponsor funded *

f. # of Industry Sponsored Trials *

g. # of Industry Sponsored Device Trials *

h. Was your site able to reach it's enrollment for this sub-specialty? *

Yes

If not, please provide a brief description *

Sub-specialty 5

Specialty Area / Question 5 *

a. In the past year, how many studies were conducted in this sub-specialty? *

b. # of Investigator Initiated Studies- not sponsored funded *

c. # of Investigator Initiated Studies- sponsored funded *

d. # of Investigator Initiated Device Studies- not sponsor funded *

e. # of Investigator Initiated Device Studies- sponsor funded *

f. # of Industry Sponsored Trials *

g. # of Industry Sponsored Device Trials *

h. Was your site able to reach it's enrollment for this sub-specialty? *

Yes

If not, please provide a brief description *

Section 5: Research Team Information

3. Is your research team part of a centralized clinical research infrastructure? *

Centralized infrastructure

Decentralized infrastructure

Hybrid infrastructure (both Centralized and Decentralized infrastructure

4. How many clinical trials on average are you managing per year? *

5. Of those clinical trials noted in Question 4, how many are the following

(amounts in boxes should sum to 100%)

a. Percent of Industry sponsored under an IND *

b. Percent of Investigator Initiated Drug Trials *

c. Percent of Industry Sponsored Device Trials *

d. Percent of Consortium Trials *

e. Percent of Registry Trials *

f. Percent Other, provide brief description

FTEs

How many clinical trials on average are you managing per year? *

6. Are any members of the site research team certified through ACRP or SoCRA? *

Yes

How many? *

7. Does your Institution encourage research certification? *

Yes, it is encouraged and they cover ALL the associated costs

Yes, it is encouraged and they pay for a PORTION of the cost

Yes, it is encouraged but they do not pay for any of the associated costs

No, it is not encouraged

8. How is specimen collection and processing handled at your site? (Please check all that apply) *

Study nurse collects specimens, processes them and ships them

Study nurse collects specimens, study coordinator / study team processes them and ships them

Subjects are sent to lab where samples are drawn, then study team processes and ships specimens

Subjects are sent to lab where samples are drawn, processed and shipped

OtherOther

Section 6: Research Team Training

1. Please describe the clinical research training the research team has completed. (Please check all that apply) *

Human Subjects Protection- OTHER

Human Subjects Protection - CITI

Institution developed clinical research training

Good Clinical Practice - Investigational Drugs/Devices- CITI

Good Clinical Practice - Investigational Drugs/Devices- OTHER

Human Subjects Protection 'Other', please describe *

CGP Investigational Drugs/Devices 'Other', please describe *

2. If training is listed in Question 1, is this training required or suggested? *

Required

Suggested

3. If training listed in Question 1 is required, does it apply to all members of the study team or select members? *

All

Select

3a. Please indicate the select groups *

4. Does your Institution support or fund continuing education opportunities for staff to educational conferences that relate to clinical research? *

Yes, but does not fund

Yes, Institution does fund

Section 7: Research Compliance Information

1. Does your Institution / site have Clinical Research Standard Operating Procedures (SOPs) in place? *

Yes

2. Has the Institution, site or principal investigator at the Institution been audited by a regulatory agency (FDA, OIG, OHRP) in the past 2 years? *

Yes

3. Which agency conducted the audit (please check all that apply)?

FDA

OIG

OHRP

4. What was the reason for the audit (please check all that apply)?

5. What was the outcome of the audit?

No Action Indicated

Voluntary Action Indicated

Official Action Indicated

Section 8: Research Facility Information

Provide any comments or additional facilities / equipment / resources not noted in the chart above

Section 9: Investigational Drug / Product Information

1. Does your site employ a research pharmacist? *

Yes, we have research dedicated staff

Yes, we have research dedicated staff as part of the hospital pharmacy services

No, we use hospital provided pharmacy services

OtherOther

2. If your site has a research pharmacist(s), how many full-time equivalents (FTEs) do you have? *

3. Is all investigational product stored separately from non-investigational medications? *

Yes

Most (please explain)

No (please specify where it is stored)

No, Please specify where it is stored *

Most, Please briefly explain *

4. Does the Institution/site require Good Clinical Practice (GCP) training for personnel managing investigational products? *

Yes

5. Does the Institution/site have Standard Operating Procedures (SOPs) for investigational drug receipt, management, temperature monitoring and closeout? *

Yes

Other: Any other information that you would like to share regarding your site that is unique to conducting pediatric clinical trials?

Required Files

When submitting this questionnaire, please also provide the following attachments:

CV of Physician Site Champion

Maximum upload size: 67.11MB

Organizational Chart for your clinical research team

Maximum upload size: 67.11MB

Copies of any 483s in the past 2 years (if applicable)

Maximum upload size: 67.11MB

I‑ACT for Children Site Network Questionnaire

Site Network Questionnaire

Point of Contact

Physician Site Champion

Please identify who is completing this form

Section 1: General Information

Section 1

5. What percentage of each racial background best composes your center’s population of care (amounts in the boxes should sum to 100%):

6. What percentage of Non Hispanic/Latino ethnic background best composes your center’s population of care (amounts in the boxes should sum to 100%):

Section 2: Satellite Site Information

Section 2

Section 3: Contact, IRB & Other Review Information

Section 3

Step 1: Please identify any and all areas in which your site conducts clinical trials by checking the box to the left, next to the sub-specialty.

Step 2: Please indicate the Top 5 Therapeutic Areas (from the list above) in which your site highly performs, has highly engaged principal investigators and research staff, achieves enrollment targets in most projects, etc.

We would like to obtain performance data about the 5 key areas you identified as your site’s research strengths. Would you please provide the following:

Sub-specialty 1

Sub-specialty 2

Sub-specialty 3

Sub-specialty 4

Sub-specialty 5

Section 5: Research Team Information

Section 5

2. For the core clinical research team please indicate the number of staff

5. Of those clinical trials noted in Question 4, how many are the following

FTEs

Section 6: Research Team Training

Section 7: Research Compliance Information

Section 8: Research Facility Information

Section 9: Investigational Drug / Product Information

Required Files