Site Information Form

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Summary of Site Experience

Site Setting(Required)

Site Experience:(Required)

Staff/ Communication of Patient Safety

Physicians/ Mid-levels

Sub I’s:(Required)

Pharmacists

Pharmacist or techs:(Required)

Study Staff

Study staff with credentials:(Required)

Training

How does your site ensure that study staff are trained and have adequate experience to perform clinical research?(Required)

How is protocol specific training conducted post SIV?(Required)

Does your staff have GCP training? What training provider? How often is it renewed? Are lab staff IATA certified?(Required)

How does your site demonstrate education and provide that to the sponsor?(Required)

Clinic Hours

What are your clinic hours?(Required)

How do you ensure adequate staff coverage?(Required)

Do you allow for extended hours?(Required)

What assessments, if any, can you perform on the weekends?(Required)

Patient Treatment Oversight

How can you ensure that patients always have a provider during required study assessments?(Required)

How do you communicate patient issues with other staff?(Required)

How do you communicate patient status (enrollment, decision to take patient off study, etc.)?(Required)

Patient Recruitment

Overview of Patient Population

Patient population:(Required)

Therapeutic areas:(Required)

Recruitment

How do you recruit for studies?(Required)

What communications are in place to recruit patients?(Required)

Advertising

How do you advertise for a study?(Required)

What documents would be best that the sponsor could provide?(Required)

Patient Location

How far away do patients typically travel?(Required)

Would you request additional assistance for those patients?(Required)

Patient Retention

How do you keep patients on a study?(Required)

What services do you offer to deal with “visit fatigue” after a patient has been on the study for extensive amounts of time?(Required)

Consenting/Screening Process Consult Visit

How do you determine which study is right for a patient?(Required)

Describe the consenting process. Note this should include how you ensure the patient has had apt time to review and decide to participate on the study.(Required)

Screening Visit

Once the patient has indicated they would like to start a study, what are their next steps? How do you ensure a current version of the consent is used?(Required)

Who reviews the consent with the patient?(Required)

Is the principal investigator available for additional questions?(Required)

How does you site ensure comprehension of the ICF by the patient?(Required)

Who signs the ICF?(Required)

Do you provide a copy of the signed consent to the patient?(Required)

Where is the signed consent stored?(Required)

Consenting/Screening Process Consent Contents

Are you able to use the sponsor given consent? If not, provide how that helps your patients Are there any state or local laws of language that must be included in your site’s version of the consent?(Required)

How do you document consent including date, time, version, type of consent (initial, re-consent, phone consent), any SOC procedures performed prior to consent that will be used for the study, and any other notes applicable?(Required)

Language Translation

What is the process for a non-native speaking patient?(Required)

Other than the language this CV is written in, are there additional languages your site will need to have the consent translated in?(Required)

Medical Records

What EMR system do you use (name, version)?(Required)

Can you provide a Part 11 compliance document? (Tip: create a document that shows each of the requirements for Part 11, and how the system complies with them.)(Required)

How do you collect medical records and upload to your system?(Required)

Source Documentation

How is source documented?(Required)

Are there any records that are paper records?(Required)

How is new data (AEs, labs, scans, etc.) reviewed by the PI for oversite?(Required)

Adverse Event Capturing

How are Adverse Events and Concomitant Medications captured?(Required)

What is the 24 hour telephone number or other instruction for patients experiencing Adverse Events?(Required)

Procedures

Temperature Monitoring

What equipment/areas are temperature monitored?(Required)

Are backup generators available and where are they?(Required)

What systems are used for temperature monitoring?(Required)

What is the backup temperature monitoring system?(Required)

Can temperature monitoring logs be provided upon request?(Required)

Temperature Excursion

Is your system alarmed?(Required)

Who gets notified and is responsible for excursions?(Required)

What is the process for drugs/ samples that were impacted or potentially impacted?(Required)

Patient Emergency

Do you have an AED?(Required)

Do you have walled and or portable oxygen?(Required)

Where are emergency medications kept?(Required)

What happens if a patient emergency exceeds what research staff can handle? How far away is the nearest emergency room?(Required)

Protection / Recovery

Are electronic medical charts backed up?(Required)

If paper documents are devastated, what is the process for recovery?(Required)

FDA Audits

Have you ever had an FDA audit?(Required)

What were the issues?(Required)

Can you provide 483s if applicable?(Required)

On- Site Facilities/ Capabilities Exam Rooms

How many exam rooms do you have?(Required)

List what procedures are performed in each room (ex, do you give treatment, or do you only use for physical exams?)(Required)

Intake Procedures

Where are Vital signs taken?(Required)

What equipment do you have? (Automatic BP [include sizes: child, adult, extra-large], Manual BP [include sizes: child, adult, extra-large], Pulse Oximeter, Scale, Stadiometer, etc.)(Required)

Treatment Area

How many infusion chairs do you have?(Required)

How many infusion pumps do you have? What brand?(Required)

Where is the treatment area located in proximity to the pharmacy? If not located in immediate vicinity, document transportation policy.(Required)

What activities does you site offer for patients staying long hours (if applicable)?(Required)

ECG monitoring

How many site ECG machines do you have?(Required)

Which formula do they calculate (Frederica and Bazett)?(Required)

How many site holter monitors do you have?(Required)

Are there any specific processes for centrally read ECGs?(Required)

Research Laboratory Equipment

What equipment does this area hold? Examples of blood processing equipment includes:(Required)

If you do not have any of this equipment, will you accommodate any of this equipment if the sponsor were to provide?(Required)

Central Lab Collection

What is your process for collection of central labs? Lab kits stored?(Required)

How do you organize collection of multiple central labs?(Required)

Central Lab Processing

How many lab areas do you have to process/ship central labs? Are they self-contained?(Required)

How long can samples be stored? Explain how back up samples are stored separately from primary samples.(Required)

Archival Tissue/ Tissue Procurement

Can archival tissue be provided?(Required)

Is there a limit of slides vs blocks?(Required)

How long does it take to procure samples?(Required)

Do you have your own storage of archival tissue?(Required)

What are the procedures for collection of fresh biopsies?(Required)

What preservation methods can be used for fresh biopsy samples?(Required)

Can the lab technicians process a sample according to protocol prior to shipment or are there specific processes that must be done for all samples?(Required)

Where will tissue be stored until shipment?(Required)

Investigational Drug Repository Equipment

What equipment does this area hold? Examples of pharmacy equipment includes:(Required)

laminar flow hoods

Dedicated, -80°C Freezers (alarm sounds at 86° Celsius)

Dedicated, -20°C Freezer (alarm sounds at 12° Celsius)

Dedicated, 2-8°C Refrigerator (alarm sounds at 8° Celsius)

liquid nitrogen tanks

If you do not have any of this equipment, will you accommodate any of this equipment if the sponsor were to provide?(Required)

Security

If this is not a dedicated research pharmacy, explain how drugs are stored separately from non-investigational drugs.(Required)

Explain how the area is double-locked. Who has access to the pharmacy area?(Required)

Drug Administration

How is investigator oversight of treatment labs and drug orders performed/documented? What double checks are done by staff to ensure patient is “good to treat”?(Required)

Who preps the drug?(Required)

What double checks are done by staff to ensure drug is dispensed appropriately?(Required)

How is drug transported to the staff that will give the drug to the patient?(Required)

Who is responsible for giving drug to the patient?(Required)

What double checks are done by staff to ensure drug is administered appropriately?(Required)

Drug Accountability

Can you use sponsor accountability forms? If not, will you be amenable to providing the sponsor with a copy of the site-specific forms for review?(Required)

Will patients be provided with sponsor drug diaries? If not, will you be amenable to providing the sponsor with a copy of the site-specific forms for review?(Required)

Drug Destruction

Is site amenable to returning unused IP per sponsor’s guidelines?(Required)

Can used vials be kept or will boxes/labels be kept for drug accountability?(Required)

Can site destroy IP onsite? If so, how are IP vials destroyed by site?(Required)

How is destruction documented?(Required)

Can you provide the SOP for drug destruction?(Required)

Off Site Facilities/Vendors

Facilities Used for Special Procedures

*Please note that this list is not comprehensive. It includes commonly requested vendors.

Safety Laboratory

Distance

What procedures do they perform?(Required)

How are safety labs provided to PI in a timely manner?(Required)

What is the process for approving labs to treat a patient?(Required)

Procedures

How far away is the location?(Required)

Scheduling

How long does it typically take to have standard CBC & Chemistry results to the PI?(Required)

Radiology / Tumor Measurements

Distance

What procedures do they perform?(Required)

Who reviews measurements for tumor assessment?(Required)

How do you handle potential doctor-to-doctor differences?(Required)

What tumor assessments do you have experience with?(Required)

Procedures

How far away is the location?(Required)

Scheduling

How long does it take for procedures to be schedule?(Required)

How long does it take for reports to be provided to Sponsor?(Required)

Administrative Processes

Staff/ Communication of Trial Information to Sites

Administrative Processes

Regulatory Specialists:(Required)

Back up:(Required)

Budget/ Contract Specialists:(Required)

Back up:(Required)

Data Specialists:(Required)

Back up:(Required)

Role Specific Training

How does your site demonstrate education and provide that to the sponsor?(Required)

Delegation of Authority

Can you use the sponsor’s Delegation form?(Required)

When will you provide updated Delegation logs?(Required)

PI Oversight

How can you ensure that regulatory documents are reviewed by the PI?(Required)

How do you communicate regulatory updates with other staff?(Required)

Monitoring

Scheduling a Monitoring Visit

How often are visits mandated by the site if there are active patients on a trial?(Required)

Is there a limit to the number and how often the visits can be scheduled?(Required)

Is there a limit to the number of monitors (& co-monitors) that can be accommodated?(Required)

Who is the contact for scheduling monitoring visits?(Required)

Do each piece of the visit (PI, lab, pharmacy, data review, and regulatory review) need to be scheduled by separate people?(Required)

What are the monitoring hours of operation?(Required)

Description of Monitoring Facilities

How many spaces are reserved for CRA monitoring?(Required)

What equipment does the area have for CRA monitoring? (Ex. copier phone line, desktop monitor, Wi-Fi, etc.)(Required)

Monitor’s access to the EMR

What type of access will the monitors have to the EMR? (read-only, over the shoulder, etc.)(Required)

When are CRA monitors given access to the EMR?(Required)

Remote Monitoring

Is remote monitoring allowed?(Required)

Are there any stipulations for the study for remote monitoring to be considered?(Required)

Regulatory Binders

Regulatory Documents

Are regulatory binders kept in paper or electronically? If both, describe which ones are electronic vs paper.(Required)

Paper documents kept: (on site or corporate)(Required)

What is the process for uploading or filing documents signed in paper?(Required)

Briefly describe how your regulatory binder is set up.(Required)

Can wet inks be requested?(Required)

How long are records stored and where at (for paper records)?(Required)

Protection / Recovery

Are electronic regulatory documents backed up?(Required)

If paper documents are devastated, what is the process for recovery?(Required)

If electronic regulatory binders: Is there a training?(Required)

CRA Monitor eReg Access

When are CRA monitors given access to the documents (on site vs 24/7)?(Required)

CRO Regulatory Portals

Does the site allow integrated site files or uploading to sponsor regulatory portals? If so, what portals are allowed?(Required)

Patient Safety Reporting

Unanticipated Problems

How are IND safety reports processed?(Required)

What events will the PI and IRB be made aware of?(Required)

Serious Adverse Events

What is the process for making Sponsor aware of a Serious Adverse Event within 24 hours?(Required)

Protocol Deviations

How are protocol deviations handled?(Required)

Are deviations categorized in any way at your site? If so, how?(Required)

Data Entry Timelines

How many days after visit is data entered into EDC?(Required)

How many days for query resolution?(Required)

Access Experience

Who at the site level receives access?(Required)

What EDCs do you have experience with? (Ex. RAVE, Inform, Oracle, Data Labs, iMedNet, Tempo, etc.)(Required)

EDC integration

Do you have any EDCs that you have integrated with your EMR?(Required)

FDA Audits

How do you handle any issues brought to your attention that require process changes?(Required)

QA monitoring

Do you have a QA team that can be reached?(Required)

Development Timelines

Required Documents

What documents are required for your site to get started developing a trial?(Required)

Overall

What is the typical development timeline from document receipt to activation?(Required)

SIV Dates

Do you have any requirements prior to scheduling SIV?(Required)

Just In Time

Do you have processes that will identify the patient for a trial prior to developing the study at the site, then ensuring the trial is running within 2 weeks of site selection?(Required)