rave data entry guidelines s1400 & sub-studies 16e... · 2018-02-06 · rave data entry...

RAVE DATA ENTRY GUIDELINES

S1400 & SUB-STUDIES

Protocol Ver.

1/8/18

Doc. Version 05FEB2018 Page 1 of 44

Case Report Forms

S1400 Forms

Onstudy: Patient & Disease Description Form 3

Onstudy: Prior Treatment Form 4

Source Documentation: Baseline 5

S1400 Request for Sub-study Reassignment 6

S1400 Request for NEW Sub-study Assignment 7

Notice of Progression 8

Status Update Form 9

Intention not to Register Form 10

Follow-up Form 11

Notice of Death Form 12

S1400A, G, and I Sub-Study Forms

Onstudy: Patient & Disease Description Form 13

Onstudy: Prior Treatment 14

Onstudy: Laboratory Values 15

Pre-Treatment Laboratory Values 17

Smoking Status Assessment 18

Source Documentation: Baseline 19

Tumor: Assessment – Disease Assessment 20

Tumor: Target Lesions 21

Tumor: Non-Target Disease 22

Follow-up Tumor: Assessment 23

Treatment Form 24

Treatment Dose Modification Due to AE Form 25

Adverse Events: Assessment 26

Adverse Events: Report 27

Immune-Related Adverse Event – S1400I 30

Site(s) of Progression or Relapse 31

Off Treatment Notice 32

Advanced NSCLC Follow-up Form 33

Notice of Death Form 34


Case Report Forms (Cont.)

S1400F & S1400K Sub-study Forms

Eligibility Criteria 35

Onstudy: Patient and Disease Description 36

Onstudy: Laboratory Values 36

Onstudy: Prior Treatment 38

Treatment Form 39

Adverse Events: Report 41

Immune-Related Adverse Event 43

End of Study 44


If the patient’s tumor tissue was tested for PD-L1 expression, please

complete this section utilizing information from the PD-L1 report.

The “Assay” refers to the antibody, not the lab that performed the

testing.

If you are unsure about how to complete any of these fields, upload

a redacted copy of the associated PD-L1 report into the “Source

Documentation: Baseline” folder or email the DC’s a copy

([email protected]) to provide guidance.

S1400 Screening Forms

Onstudy: Patient & Disease Description Form

As there are several different conversion charts available for Karnofsky to Zubrod, it is important that

the Zubrod scale be used. If the Karnofsky is used, the Zubrod value must also be documented in

the medical record.

This form is due within 7 days of registration to S1400. Late submission > 3 months is

considered a major data delinquency deficiency for baseline forms.

Height, Weight & P/S must be

obtained within 28 days prior to

study entry. The values closest to

the registration date are reported.

The AJCC clinical stage is the stage at

the time of study entry, not at

original diagnosis. If patient has

metastatic disease, either M1a or

M1b are entered.

If T and N stage are unknown, enter

TX, NX, M1a, for example. If patient has had a cigarette within the past

year, they are considered a current smoker.

The date of current staging is the

date of the most recent test to

assess disease (usually a scan or

biopsy). It is not the date of a

physical exam unless a measurement

of a lesion is done at the visit (e.g.

skin lesion assessed).

mailto:[email protected]



Onstudy: Prior Treatment Form

The patient is considered a screening patient if they have progressed on current

systemic therapy for stage IV or recurrent disease at the time of registration.

The patient is considered a pre-screening patient if they are currently receiving

systemic treatment for stage IV or recurrent disease and have not progressed

yet.

This form is due within 7 days of registration to S1400. Late submission >3

months is considered a major data delinquency deficiency for baseline

forms.

If patient registered as:

Pre-screening, the

answer would be ‘No’,

and the following

treatment questions

would be left blank.

Screening, enter ‘Yes’

& answer the next

questions.

For Screening patients:

Enter the last date of any

treatment received, not

necessarily the date of

the last platinum (this

includes Nivolumab).

Enter the date of the first

scan or biopsy that

confirmed progression,

after the most recent

course of chemotherapy

but BEFORE registration

to this step.

This is the date the form was signed by the pathologist, not the date of the

pathology report, or when the specimen was obtained or submitted. The form

cannot be signed by the CRA/nurse.

The Local Pathology Review Form is due within 7 days of Screening/Pre-

Screening Registration. Retain a copy of this form in the patient’s research file.



Source Documentation: Baseline

Within 7 days of registration, upload:

The pathology report for the initial diagnosis documenting histological confirmation of

squamous cell carcinoma and lung primary

The Local Pathology Review Form signed by the pathologist prior to specimen submission.

Information Regarding the S1400 Local Pathology Review Form

Please ensure you are using the most recent version of the Local Pathology Review Form by

checking the version number located on the bottom right-hand side of the form.

As of October 2017, the most recent version of the Local Pathology Review Form is Version 1.3.

The form version in the Master Form Set will always be the most up-to-date; the Master Form Set

can be accessed on the S1400 protocol pages on CTSU.org and SWOG.org.

If another specimen is submitted, a second Local Pathology Review Form should be completed.

Save a copy of all forms for source documentation of adequate tissue confirmation.

The date of procedure is the date the test was done, not the date the document is uploaded or

the date of the report.



S1400 Request for Sub-study Reassignment

This form is submitted after receiving a sub-study assignment if the patient does not fulfill the assigned sub-study-specific eligibility criteria.

If needed, this form can

be added from the “Add

Event” drop down box on

the subject tab.



S1400 Request for NEW Sub-study Assignment

This form is ONLY for patients who have progressed on a sub-study and wish to register to a new sub-study.

If needed, this form can

be added from the “Add

Event” drop down box on

the subject tab.



Notice of Progression

For pre-screening patients, submit this form within 7 days of progression on current therapy.

This form will trigger the sub-study assignment for the patient the next morning (provided 16 days

have passed since the S1400 Pre-screening registration).



Status Update Form

Submit this form within 21 days of receiving a sub-study assignment, if the patient

has not yet registered to their assigned sub-study. If the Notice of Intention not to

Register is submitted, this form is no longer required.


If needed, this form can be added from the “Add Event” drop down box

on the subject tab.


Notice of Intention Not to Register

Submit this form within 7 days of the decision not to register patient to a sub-study.

Although the patient will not go onto a sub-study, follow-up continues per Section 14 of the

protocol.

This is the date documented

in the medical record that

the physician decided the

patient will not go on to a

sub-study.

If tissue was inadequate, there should be documentation whether or not the

patient allowed a second biopsy.

If patient was not eligible for the sub-study, there should be documentation

that a request for sub-study reassignment was submitted, if applicable.

This is the last documented

contact with the patient.

If source documents indicate

that patient will receive

additional treatment, report

it here.



Follow-up Form

Submit this form at the following time points:

For screening/pre-screening patients: Every three months for the first year, then every six months for

the second year and annually thereafter after until sub-study registration, the end of Year 3, or

patient’s death (whichever comes first).

For patients who will not be registered to a sub-study: every six months for two years and at the end

of Year 3, or patient’s death.

This includes treatment

with commercial agent(s)

that patient received

after going off treatment

(e.g. Ipilimumab).

This is cranial radiation

when there are no signs

of metastatic disease to

the brain.

If any clinic visits, phone

calls, labs, scans, biopsies,

etc. were done since the

last activity date, this

should be ‘Yes.’



Notice of Death Form

Submit this form within 28 days of knowledge of death.

Source documentation must

be available to support the

cause of death that is

reported.

The source(s) indicated will be

viewed at the time of audit.

More than one source can be

selected.


Record the values closest to the date prior to sub-study registration.

Record the stage at the time of sub-study registration. If metastatic disease is present, this is either M1a or M1b. registration.

The stop date & dose of corticosteroids must be documented in the medical record.

If the patient has

treated brain

metastasis, and

there is no

subsequent scan

demonstrating

resolution of the

lesions, answer

‘Yes’.

If unsure about how to complete this section, email [email protected] or upload into the Rave “Source Documentation: Baseline” folder a redacted copy of the PD-L1 report for assistance.

S1400 Sub-Study Forms

Onstudy: Patient & Disease Description Form

Submit this form within 7 days of registration to a sub-study.




Palliative radiation

means for pain or

symptom control,

not for a disease

response (e.g. spine

RT for pain control).

This is generally

radiation for stage

I – III lung cancer.

This is major

surgery, not a

biopsy or port

placement.

If more than one

drug, please list each

drug on a separate

line. Include all

treatment for this

cancer (stage I – IV).

1400 Sub-Study Forms

Onstudy: Prior Treatment

For S1400G: This is the best response to the patient’s prior platinum-based chemotherapy

treatment. Per S1400G eligibility, the patient must be platinum-sensitive. This question is only on the

S1400G Prior Treatment Form.

Submit this form within 7 days of registration to a sub-study.



Onstudy: Laboratory Values

Baseline: record the values obtained closest to the date of registration.

Treatment cycles: record the values obtained on or just prior to Day 1 of the next cycle (e.g. For

Cycle 1, you would record Cycle 2/Day 1 labs).

Submit this form

Baseline: Within 7 days of registration

Treatment: Within 7 days after each cycle

If no 24-hour urine is done, leave the measured creatinine clearance blank. The calculated creatinine clearance value auto populates from the data entered into RAVE.



Sub-study I:

Submit this form immediately within 7 days after each cycle.

This is Free T3 & T4, not total T3 & T4. For conversion to ng/dL see: http://endmemo.com/sconvert/pg_mlng_dl.php

http://endmemo.com/sconvert/pg_mlng_dl.php

http://endmemo.com/sconvert/pg_mlng_dl.php



Pre-Treatment Laboratory Values

Enter ‘Yes’ if additional laboratory values were obtained before Treatment on Cycle 1, Day 1.

If ‘Yes,’ the Pre-Treatment Lab Form will appear. Enter the Cycle 1 Day 1 labs on this form.

The “Calculated creatinine clearance” will auto populate after the Cycle 1 weight is entered on the Cycle 1 Treatment form. An overdue icon may appear until the Cycle 1 Treatment form is submitted, but no further action is required on this form.



Smoking Status Assessment

These questions should be answered by the patient at Baseline & at Off-Treatment. A copy of this

form can be printed for the patient to complete. There should be documentation of the date and who

completed the form (e.g. If patient completes the form, they should sign and date it).

The form can be obtained from the Master Forms Set available on the protocol page on

both the SWOG and CTSU websites. Scroll through the Master Forms Set to the

Smoking Status Assessment Form.

If utilizing a progress note to support the data entered on this form, it should be clear that these

questions were asked specifically of the patient.

This form is due within 7 days of registration to the sub-study & within 7 days of going off-

treatment.

If patient answers ‘less than one year’, they are considered a current smoker.



Source Documentation: Baseline

Upload the reports for:

CT or MRI brain scan

CT of the Chest/Abdomen/Pelvis

Any other report used to assess baseline disease PRIOR to sub-study registration

These documents should be uploaded in RAVE within 7 days of registration to the sub-study.

Click on the browse button to locate

the document on your computer to

upload.

This should be the date the scan or

procedure was performed, not the

date of the report.



Baseline Tumor: Assessment – Disease Assessment

Submit this form within 7 days of sub-study registration.

All scans used to assess disease are to be uploaded into TRIAD within 7 days per Section 15.

If CT or MRI brain scan, or other negative test was done, list it here.

If a PET scan was done within 42 days prior to registration to the sub-study, enter ‘Yes’ and the date.

If following target lesions – enter yes.

If following non-target lesions – enter yes.

If the physician is giving the reported measurements, then physician should be listed here.



Tumor: Target Lesions

Source documentation must exist to support measurements entered here.

The same method of measurement at baseline must be used at each assessment.

For lymph nodes, record the smallest (short axis) diameter (must be > 1.5 cm to be a measurable

lesion).

Nodules are generally not considered lymph nodes.

This value auto

populates.



Tumor: Non-Target Disease

Non-measurable lesions can include:

Measurable lesions that were not selected as target lesions. Since only two lesions per organ and five lesions in total can be selected as target lesions, any additional lesions should be followed as non-target disease.

Small lesions (longest diameter < 1.0 cm or pathologic lymph nodes with ≥ 1.0 cm to <1.5 cm short axis). Note: Lymph nodes that have a short axis < 1.0 cm (10 mm) are considered non-pathological and should not be recorded or followed.

Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast disease, and abdominal masses (not followed by CT or MRI).

Previously radiated lesions that have not progressed.

All baseline sites of disease must be captured somewhere on the Baseline Tumor

forms (either as target lesions or non-target disease).


For sub-study A and sub-study F, patient must have a confirmation scan >

28 days from initial scan showing progression to meet irProgression criteria

in section 10.0. If progression is shown on the subsequent scan, the date of

the initial progression scan is reported as the progression date.


Follow-up Tumor: Assessment

Source Documentation: Follow up – Follow-up Tumor Assessment Form

Scan reports must be uploaded to RAVE in addition to submitting the scan(s) within 7 days to

TRIAD per Section 15.

Enter any new lesion(s)

here. Presence of new

lesions constitutes

progression. If the

report states lesion

increased in size from

prior scan, then it

probably is not a new

lesion.

If symptomatic

deterioration is yes,

there should be

documentation in the

Medical Record that

the patient’s

performance status

has decreased.

If patient progressed,

answer ‘No’ to

symptomatic

deterioration.

For S1400I

only (added

10/2/17).



Treatment Form

** Be conscious of the dates. There should be no gaps in dates between cycles. **

Sub-study I:

This is the date treatment

started for this cycle.

These values should be from

Day 1 of the cycle before

treatment is given. Utilize your

institution’s formula for BSA.

This should be Day 1 of the

next cycle or 30 days after the

last treatment was given if

removed from study

treatment.

This date should be at the end

of the cycle & can be Day 1 of

the next cycle (when the

toxicities are assessed).

Complete the row only for the medication the patient is taking. Leave the others blank.



Sub-study G:

Treatment Dose Modification Due to AE Form

If treatment was held, reduced or omitted, record the reason on this form.

Pharmacokinetic (PK) analysis is required for all patients on S1400G. Please see section 15.3 for additional details

regarding specimen collection and submission.


S1400 Sub-study Forms

Adverse Events: Assessment

Review all toxicities occurring throughout the cycle. If the toxicity assessment is done on Day 1 of

the next cycle (before treatment), then those toxicities should be recorded in the prior cycle. For

example, if patient is found to have a rash at the toxicity assessment on Day 1 of Cycle 2, this is

reported in Cycle 1.

Make sure and check all laboratory values. If any laboratory values are out of range, they must be

graded per CTCAE 4.0 and reported as an adverse event. If an adverse event occurs in the labs

drawn on Day 1 of a cycle, the toxicity is reported for the previous cycle.

DO NOT report a condition existing at baseline unless it increases in grade, or returns to normal and

then returns.

Sub-study A has adverse events of special interest that require expedited reporting in CTEP-AERS.

> Grade 1 pneumonitis

> Grade 2 AST or ALT if after evaluation it meets Hy’s Law

Grade 2 bilirubin

Any grade Infusion Reactions

Any Grade Hypersensitivity Reactions.

Sub-study G has adverse events of special interest that require expedited reporting in CTEP-AERS.

> Grade 2 AST or ALT

> Grade 2 bilirubin

Sub-study F also has adverse events of special interest, which are outlined in the S1400F forms

section.

These dates should

match the reporting

period on the treatment

form, except for the last

cycle (see help text).

All toxicities grade 1 – 5

are reported even if the

event is felt not to be

clinically significant. The

only exceptions are

those present at baseline

that have not worsened

in grade or reoccurred.



Adverse Events: Report

DO NOT record a condition existing prior to registration.

If a toxicity continues to the next cycle, check ‘AE ongoing,’ and add that toxicity to the next cycle’s

adverse event report with the start date from the previous report period. Continue adding the AE for

each cycle until it ends. Enter the end date on the cycle where the AE ended.

If a baseline toxicity resolves during treatment, then comes back, you will then add that adverse

event to the report.

Be sure to check all laboratory values done throughout the cycle and not just the ones done on Day1

of the subsequent cycle. Laboratory values that are out of range are reported, even if not clinically

significant.



Adverse Events: Report – For S1400A MEDI4736 patients only

For patients who received MEDI4736 on S1400A, retrospective data collection regarding immune-

related adverse events (irAEs) will be required starting with the release of Lung-MAP Revision #9/10

on 10/2/2017. On this form, please indicate if any immune-related AEs were seen during the cycle.

If “Yes” is selected as the response to the question “Were any adverse events seen in this reporting

period immune-related?”, for each adverse event listed in the cycle, please indicate “Yes” or “No” to

the “Is the AE immune-related?” field that generates.



Adverse Events: Report – S1400I

For all patients on S1400I, the Adverse Events: Report form has been updated with the release of

Lung-MAP Revision #9/10 on 10/2/2017. Both retrospective and ongoing data collection regarding

immune-related adverse events (irAEs) will be required. On this form, please indicate if any irAEs

were seen during the cycle. Please also note the addition of the “CTEP-AERS report ticket number”

field for correlation with expedited SAE reporting, and the updated form instructions.

If “Yes” is selected as the response to the question “Were any adverse events seen in this reporting

period immune-related?”, for each adverse event listed in the cycle, please indicate “Yes” or “No” to

the “Is the AE immune-related?” field that generates.

If the adverse event warranted expedited

reporting via the CTEP-AERS system, please

enter the CTEP-AERS report ticket number

here. The grade and attribution of the event

should match the CTEP-AERS report.

If any AE’s in this reporting period were immune-related, this

question must be answered for all loglines. A separate

“Immune-Related Adverse Event” supplemental form will

generate for each adverse event term where this question is

answered “Yes”.



Immune-Related Adverse Event Form – S1400I

If “Yes” is selected as the response to the question “Is the AE immune-related?” for a specific

adverse event, a supplemental “Immune-Related Adverse Event” form will be generated for each

immune-related adverse event in the cycle. A separate form will need to be completed for each

immune-related adverse event.

Use “Add a new Log line” as needed to list multiple concomitant agents.

For concomitant agents administered for the treatment of immune-related AEs, please only list a

stop date within the corresponding cycle; if treatment was still ongoing at the end of the cycle, please

mark the “Ongoing” checkbox instead.



Site(s) of Progression or Relapse

This date should

match the date of the

scan demonstrating

progression.

This is disease status

at the primary lung

site, on the same side.

These are lymph

nodes, not nodules.

Check all that apply.

Any lesion that is

new, and not just

enlarged, should be

reported on the NEW

LESIONS section of

the Follow-up: Tumor

Assessment Form.



Off Treatment Notice

If they received even

one dose while on

protocol, this is ‘Yes’.

If off treatment for

more than one reason

(e.g. symptomatic

deterioration and

progression) record

the main reason the

patient came off

study. Explain in

comments.

If the patient came off treatment for:

Progression: enter the date of the scan that demonstrated progression

Positive biopsy that confirmed progression seen on a scan: enter the date of

the scan, not the date of the biopsy.

Toxicity or Patient Decision: enter the date the decision was made to remove

the patient from the protocol.

All toxicities continue to be collected until 30 days after the last dose of drug or

resolution to baseline.

Please note:

For patients on S1400I, serious AEs occurring within 100 days after last

administration of the protocol agents require expedited reporting.

For patients on S1400F, serious AEs occurring within 90 days after last

administration of the protocol agents require expedited reporting



Advanced NSCLC Follow-up Form

This can be from a

clinic visit or a test.

Please refer to section 14 of the sub-study protocol for the follow-up schedule.

This includes protocol

treatment that is

continued after off

treatment (e.g.

Docetaxel).

If the Off Treatment

Form indicated a

treatment that has

started during this

report period, report

yes.

If this form is being

completed at the time

of disease

progression, state yes.



Notice of Death Form

This form is due within 28 days of knowledge of death.

There must be a

source document in

the patient’s record

to support this date.



Due to new clinical research data reporting requirements, S1400F & S1400K forms have many

features that are not found in other sub-study Rave forms. This section covers the these forms and

their data entry requirements.

Eligibility Criteria

This form contains the protocol section 5 eligibility criteria. A response must be provided for each

criterion listed; none should be left blank. An example from S1400F is provided in the screenshot

below.



Onstudy: Patient and Disease Description

Onstudy: Laboratory Values - Baseline

Onstudy: Laboratory Values – Baseline

LLN, ULN, and Sample collection date are required for each lab value.

S1400F:

This is Free T3 & T4, not total T3 & T4.

If any of the data points on this form require clarification with additional comments, the comments must have the corresponding “question number” selected in the log line.



Onstudy: Laboratory Values – Baseline

LLN, ULN, and Sample collection date are required for each lab value.

S1400K:

Please note these labs specific to S1400K



Onstudy: Prior Treatment – Baseline

Examples of anti-PD-1 antibody monotherapy:

Pembrolizumab

Nivolumab

Examples of anti-PD-L1 antibody monotherapy:

Atezolizumab

Durvalumab

Avelumab

Please specify patient’s prior therapies by selecting the appropriate option in the drop-down box and typing in additional details in the adjacent text box as needed. Typing a response in the drop-down box field box will generate a non-conformant data error.

S1400F: At least one “Anti-PD-1 antibody monotherapy” and/or “Anti-PD-L1 antibody monotherapy” must be selected with additional information provided. See examples of potentially applicable monotherapy agents below.



Treatment Form

S1400F:

Patient’s vital signs should be monitored before, during, and after the infusion and recorded on the appropriate cycle treatment form. This is required for every cycle. Times should be reported in a 24-hour format.

Note these fields asking for supplemental information regarding the infusion. Times should be reported in 24-hour format.



Treatment Form

S1400K:

Record collection times for peripheral blood samples (for PK/ADA/nAB) on Cycles 1-4. Please note these samples should be logged in SWOG Specimen Tracking and shipped to Lab #201.

Note these fields asking for supplemental information regarding the infusion. Times should be reported in 24-hour format.



Adverse Events: Report

- S1400F: Moving forward, all sub-studies that utilize immunotherapy agents will collect data

regarding immune-related adverse events. For each AE listed on the S1400F form, please

indicates “Yes” or “No” in the “Is the AE immune-related?” field. For each adverse event where

“Yes” in this field is selected, a new “Immune-Related Adverse Event” form will generate in the

cycle folder.

Only for S1400F

Required for S1400F and S1400K



Adverse Events: Report (continued)

- Serious adverse events as defined in sub-study protocol section 16 should have “Yes” indicated

in the “Serious” field. Associated CTEP-AERS report ticket numbers should be added in the

corresponding field; please see section 16.0.e for instructions regarding SAE reporting.

- For S1400K, the post dosage expedited reporting requirement window is 30 days.

- For S1400F, the post dosage expedited reporting requirement window has been extended to 90

days rather than the normal 30 day requirement or until the initiation of alternative anticancer

therapy.

- Sub-study F has adverse events of special interest, and requires expedited reporting in CTEP-

AERS:

o Any Grade Diarrhea / Colitis

o Any Grade Pneumonitis / ILD

o Any Grade ALT/AST increases / hepatitis / hepatotoxicity

o Any Grade Neuropathy / neuromuscular toxicity (e.g., Guillain-Barré, and myasthenia

gravis)

o Any Grade Endocrinopathies (i.e., events of hypophysitis, hypopituitarism adrenal

insufficiency, diabetes insipidus, hyper- and hypothyroidism and type I diabetes mellitus)

o Any Grade Rash / Dermatitis

o Any Grade Nephritis / Blood creatinine increases

o Any Grade Pancreatitis (or labs suggestive of pancreatitis - increased serum lipase ,

increased serum amylase)

o Any Grade Other inflammatory responses that are rare with a potential immune-mediated

aetiology include, but are not limited to, myocarditis, pericarditis, and uveitis.



Immune-Related Adverse Event

S1400F:

This form generates for every adverse event in the “Adverse Events: Report” form that is

indicated as immune-related.

Use “Add a new Log line” as needed to list multiple concomitant agents.

For concomitant agents administered for the treatment of immune-related AEs, please only list a

stop date within the corresponding cycle; if treatment was still ongoing at the end of the cycle, please

mark the “Ongoing” checkbox instead.



End of Study Form

- Please only complete this form if the patient has gone off study, which is defined as:

o reaching or expiring prior to maximum protocol-defined follow-up of 3 years, or

o being documented as lost to follow-up per SWOG Policy #30, or

o patient withdrawal of consent to all protocol treatment and follow-up on the study, per

SWOG Policy #30.

- If the patient withdraws consent to all study follow-up, even after coming off protocol treatment,

please also complete the “Lost to Follow-Up” form in this patient’s Rave chart.

- This is not the same as removal from protocol treatment, which should be documented in the “Off

Treatment Notice.”

https://swog.org/Visitors/Download/Policies/Policy30.pdf

https://swog.org/Visitors/Download/Policies/Policy30.pdf

rave data entry guidelines s1400 & sub-studies 16e... · 2018-02-06 · rave data entry...

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